Summary of Open Oncology Protocols

Eligibility
Histologic documentation of prostate or breast adenocarcinoma or multiple myeloma. At least one bone met by radiographic imaging. No prior IV bisphosphonate treatment. No prior radiopharmaceuticals. At least 4 weeks from completion of prior radiation therapy. Prior non-investigational adjuvant and metastatic chemotherapy, biologic therapy and endocrine therapy is allowed. No current treatment with investigational medications. No brain mets.

Eligibility
Bone mets from multiple myeloma, solid tumor, or other malignancy where bisphosphanate is indicated. Planned treatment with zoledronic acid. Less than or equal to 3 doses IV ibandronate, pamidronate, or zoledronic acid in past 3 years for osteopenia or osteoporosis. Less than or equal to 90 days IV ibandronate, pamidronate, or zoledronic acid for metastatic bone disease. Willing to provide smoking history, alcohol consumption and pain assessments. Willing to undergo dental assessments and willing to provide access to prior and future dental information. No history of osteonecrosis of the jaw. No previous RT to oral maxillofacial region.

Eligibility
Histological proof of Glioblastoma. Prior treatment with Temozolomide/RT required. No other chemo is allowed. Previous participation in RTOG 0525 is allowed. Age >/=18. Performance Status >/= 60%.

Eligibility
Must have newly diagnosed, histo confirmed GBM or gliosarcoma (WHO grade IV) confirmed by central pathology office. Must have supratentorial component. Must have preop and postop MRI. Labs to be WNL. No mets detected below the tentorium or beyond the cranial vault. No Gliadel wafers permitted.

Eligibility
Study Suspended
Histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following: Involvement of 1 lymph node on routine histologic exam; ER negative >/= 1 cm; ER+ tumor >/+ 5 cms regardless of recurrence score; ER+ tumor >/= 1 cm < 5 cm with recurrence score of >/= 11(may also be enrolled in the TailorX Trial); Completed definitive breast surgery; Margins histologically free of IBC or DCIS(LCIS allowed); Must start tx between day 28 and 84 from surgery;Must have RT if undergone BCS or undergone mastectomy with tumor > 5 cm or 4+ LNs; No HER2+; No inflammatory or fixed LNs at diagnosis; No Prior Chemo/Hormonal therapy for this breast cancer; No prior anthracycline, anthracenedione or taxane; Prior use of tamoxifen(prevention) and raloxifine must be discontinued at study entry

Eligibility
ER Positive and/or PR Positive. Axillary Node Negative. Candidate for adjuvant cytotoxic therapy in addition to hormonal therapy.

Eligibility
Stage 0, 1, or 2 breast cancer. If stage 2, tumor size must be <3cm. Clear margins. No more than 3 histological positive axillary nodes. Women who are >50 with DCIS only, or over 50 with invasive, node neg and hormone positive are not eligible.

Eligibility
Postmenopausal. Pathologic or clinical stage I, II, IIIA. ER and/or PgR positive. Hormonal therapy must have consisted of an AI or a combo of up to 3 years Tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 & 5 of adjuvant hormonal therapy.

Eligibility
Incurable locally advanced or metastatic breast cancer with measurable or evaluable disease. Subjects with bone only mets that can be imaged with bone scan and MRI or bone scan and plain x-ray are eligible. Must be hormone receptor positive defined as >=10%. Must be Her2neg. Patients must have received a third generation aromatase inhibitor and progressed through prior palliative therapy, recurred while on an adjuvant aromatase inhibitor, or recurred within 12 months of completing an adjuvant aromatase inhibitor. Concurrent use of bisphophonates will be permitted on this study. Male or female subjects are ok. Female subjects must be post-menopausal. Lab values must be WNL.

Eligibility
Operable stage I, II, or IIIA invasive breast cancer. Tumors must be ER & PR negative. Must be premenopausal. Must have modified radical mastectomy or local excision plus axillary lymph node dissection and/or sentinel node. Planned treatment must include 3-8 cycles of chemotherapy.

Eligibility
8-24-2009: Temp Closed pending protocol amendment
Histo conf invasive adeno of the breast, Stage 1, II, III with no evidence of mets. Must receive standard adjuvant therapy for breast cancer.Chemo, hormone or combined is OK. Must have had a recent dental exam (within 6 months)

Eligibility
Women or men with Stage IV breast cancer which is bone-predominant.

Eligibility
Diagnosed with any phase ph+ or bcr-abl confirmed CML within 6 months of entry into the Registry. Provided informed consent.

Eligibility
Enrollment suspended pending update to Consent
Histologically confirmed adenocarcinoma of the colon that is Stage II (T3,4 NO,MO). Distal extent of tumor must be >/= 12 cm from the anal verge as determined via endoscopy or surgery. Patients must have >/= 8 lymph nodes evaluable and reported. Patients must have paraffin-embedded tumor specimen available for central evaluation and risk assessment. No isolated, distant, or intra-abdominal mets. Patients must not have presented with complete obstruction or perforation of the bowel. No prior radiation therapy for this malignancy. Must have post-operative evidence of adequate hepatic and renal function.

Eligibility
Pre-registration pathology review required prior to randomization to determine KRAS status.
Histologically documented adenocarcinoma of the colon that has been completely resected. At least 1 pathologically confirmed positive lymph node identified. No evidence of residual lymph node disease. Randomization must occur <56 days post surgery. Patients with > one synchronous primary colon cancer are eligible. Performance Status 0-2. No distant metastatic disease and no prior chemo or radiation therapy. Patients with certain cardiac conditions are ineligible.

Eligibility
Age 18-80. Biopsy proven unresectable metastatic adeno of the colon or rectum. Documented progression on prior first-line oxaliplatin-based or irinotecan-based regimen for metastatic colorectal cancer. Measurable disease of at least >1cm. First-line treatment must have been completed at least 4 weeks prior to study trx. Use of biologic agents with first-line chemotherapy permitted. Previous adjuvant regimens must have been greater than 6 months before inclusion. Adequate organ function. No prior trx with erlotinib or gefitinib. No CNS mets. No untreated or unresolved bowel obstruction. No angina or uncontrolled CHF.

Eligibility
**Pending Approval**

Eligibility
**Pending Approval**

Eligibility
Histologically proven diagnosis, via endoscopy, of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 6 weeks of registration. All disease must be encompassed in the radiotherapy field. Stage T1N1MO; T2-4,Any N, MO; Any T, Any N, M1a. Patient's total caloric intake must be at least 1500 calories a day. No evidence of tracheoesophageal fistula or invasion into the major bronchi. No prior chemotherapy for esophageal cancer.

Eligibility
**Pending Approval**

Eligibility
Must have histological or cytologically confirmed Squamous cell (SCCHN) from any primary site. Must not have nasopharyngeal carcinoma of histologic types WHO 2 or 3 squamous that originated in the skin. Patients must have SCCHN that is either recurrent, incurable by surgery or radiation, or metastatic. No prior chemo or biologic/molecular targeted therapy for recurrent or metastatic SCCHN. No prior bevacizumab.

Eligibility
Histologic or cytologic stage IIIB or IV NSCLC. No brain mets or spinal cord compression. Patients must have received 4 cycles of platinum-based doublet therapy with or without bevacizumab. No evidence of disease progression. No prior adjuvant chemo for stage I-III resected or combined modality therapy for stage III NSCLC. Cardiac restrictions apply.

Eligibility
Complete resection of Stage 1B (>4cm)- IIIA non-small cell lung cancer. Wedge resection or segmentectomy will not be accepted. Lymph node sampling is expected. Refer to protocol for specifics. Patients must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered fom surgery. Performance status 0 or 1. No prior chemo allowed. Hormonal therapy or radiation therapy as prior cancer treatment within 5 years of randomization for a malignancy over 5 years that is now considered cured is acceptable. No myocardial infarction within 12 months. Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA)will not be allowed on trial. Patients with on-going post-operative hemoptysis are not eligible. Pre-operative hemoptysis that has resolved post-operatively are eligible.

Eligibility
Histo or cyto NSCLC within 12 weeks of registration. Tumor must be completely resected. Must be stage IIIA or IIIB with no distant mets. No supraclavicular or contralateral hilar disease. For additional eligibility criteria contact Clinical Research Dept.

Eligibility
Histo or Cyto proven newly diagnosed Stage IV Adeno, large cell, squamous, or unspecified NSCLC, or recurrent disease after prev surg/RT. Pt with controlled(min 2 months)brain mets after tx&no residual neurological dysfuntion off steroids are eligible. Measurable and non-measurable disease No prior chemo, cetux, gefitinib, erlotinib or other invest agents that target EGFR Pathways.Prior RT Ok,must be 28 days post surg, ANC >/ 1500/mcl, Platelets>/ 100,000mcl, hgb>/9mg/dl. Serum Creat </IULN CrCl >/50cc/min, UPC >0.5, 24 hour <1000mg/24hour,Adq hepatic function Serum bili IULN SGOT/SGPT </2XIULN, liv mets SGOT/SGPT </5XIULN, Zubrod 0-1, No grade 2 symptomatic neuropathy-sensory, No acute/active hepatitis or uncontrolled/active infection No hx(w/i 6 mos)CVA, MI,or unstable angina, uncontrolled hypertension NY heart class Gr 2 or greater, serious cardiac arrhythmia req meds or clinically sig PVD, no known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies, pt to provide smoking hx, no prior malignancy allowed except adeq tx basil/squam cell skin, in situ cerv ca, adeq tx Stage I/II ca in remission or any other ca within 5 years.

Eligibility
Must be registered to a treatment protocol: S0536; S0424

Eligibility
Must be registered to a treatment protocol.

Eligibility
Must be registered to a treatment protocol: 8410; 8503; 8508; 8516; 8736; 8809; 8907; 8954; 9125; 9240; 9320; 9349; 9432; 9501; 9703; S9704; 9800

Eligibility
Closing due to accrual: 11-15-09
Biopsy proven malignant melanoma of cutaneous or mucosal orgin. Patients with ocular melanoma are not eligible. Patients must have unresectable disease. Patients must have Stage IV disease. Must have measurable disease. Must have negative CT/MRI of brain within 42 days of registration. No prior systemic therapy for Stage IV disease. Prior adjuvant therapy is allowed and may include cytoxic agents, but the interval from most recent exposure until registration must be at least 90 days. Prior RT is allowed if completed at least 28 days prior to registration. Adequate labs.

Eligibility
Melanoma of a cutaneous orgin. Stage T2bNo, T3a-bNo, T4a-bNo, and T1-4, N1a,2a,. Patients must complete all primary therapy (wide exicision with or without lymphadenectomy) and be randomized within 84 days of their wide excision. No prior chemotherapy, radiotherapy, or immunotherapy for melanoma allowed.

Eligibility
Must have biopsy proven stage IV cutaneous/mucosal malignant melanoma. Ocular not eligible. Measurable/non measurable disease. Must have neg Brain CT/MRI within 42 days of reg. HX Brain Mets not eligible. Zubrod 0-1,18 yrs old or older.May have received up to one prior systemic tx.for Stage IV Melanoma exc CDK inhibitors.May have rec any number of prior adjuvant Txs. SE's must be grade 1 or lower. Prior RT allowed. Prior surg(primary or stage IV) allowed. Adequate BM Function:ANC greater than/equal to 1500mcl, platelets over 100,000mcl and hemoglobin greater than/equal to 9 gm/dl w/i 28 days prior to reg. Adequate liver function:Serum bilirubin greater than/equal to 1.5 X IULN, SGOT or SGPT greater than/equal to 2.5 X IULN

Eligibility
**Pending Approval**

Eligibility
**Pending Approval**

Eligibility
Histo or Cyto confirmed pancreatic adenoca:Stg IV unresectable. Macro residual disease not eligible. No sig acites. NO prior chemo, hormonal tx, imunotx, chemo/rt for advanced/locally advanced pan ca. No prior Gemcitibine for any reason. Prior surg ok if at least 14 days prior to reg. Prior adj chemo ok 6 months prior to reg. RT ok 28 days prior as long as has meas dis. Must have Measurable and/non measurable disease. Zubrod 0-1. ANC>/1500, Plat >/100,000, Hgb >/9, Leukocytes >/3000. Bilirubin w/i IULN SGOT/SGPT </2.5 .IULN 14 days prior to reg.Ser Creat </1.5 IULN 14 days prior to reg. Fasting Glucose <120 mg/dl 14 days prior to reg. Adeq Coag PT, PTT/INR 14 days prior to reg. No hx allergic rx to chem/biol compounds sim to IMC-A12. No active acute,chronic infect req antibx. No sig cardiac probs. No known brain mets. No known HIV.

Eligibility
Previously Untreated Metastatic Hormone Refractory Prostate Cancer

Eligibility
Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (NO) or lymph node status pathologically unknown (undissected pelvic lymph nodes); Post radical prostatectomy entry PSA => 0.2 and =<2.0 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration; Must be T3N0/NX, T2NO/NX with positive prostatectomy margin and/or positive prostatic fossa; or urethral-vesical anastomosis biopsies; Gleason score of 8 or less; PSA doubling time of > 6 months; No distant mets allowed; Adequate lab values; No N1 disease.

Eligibility
Patients with histological or cytological confirmed RCC T1B, T2, T3 and T4 with any N. Patients must have undergone full surgical resection - radical or partial nephrectomy by either open or laparoscopic technique, with clear margins. Positive regional LNs require regional lymphadenectomy. Patients must not have CT or MRI evidence of residual or metastatic disease. Must have tumor specimen available for specimen submission. Must not have collecting duct or medullary carcinoma. No prior anticancer treatments for RCC either in the adjuvant or neoadjuvant setting. Patients must be 3-10 weeks post surgery at randomization in order to begin protocol treatment 4-12 weeks from surgery.

Eligibility
Must be diagnosed with colorectal, endometrial, bladder or other HNPCC cancers

Eligibility
Histologically or cytologically confirmed diagnosis of cancer.

Eligibility
**Pending Approval**