Biological Therapy in Treating Patients With Metastatic Cancer
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Purpose
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of biological therapies, including interferon alfa, interleukin-2, and tumor infiltrating lymphocytes, in treating patients with metastatic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: therapeutic tumor infiltrating lymphocytes Drug: cimetidine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 1996 |
| Study Completion Date: | January 2000 |
| Primary Completion Date: | January 2000 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the response rate and failure-free survival in patients with metastatic cancer (preferably melanoma or renal cell) treated with autologous tumor infiltrating lymphocytes (TIL), interferon alfa (IFN-A), and interleukin-2 (IL-2). II. Describe the toxic effects and costs associated with this therapy to assess risk benefit and cost benefit. III. Assess the relative value of administering low- or high-dose TIL, as well as the value of administering IFN-A before TIL, IL-2 with TIL, or cimetidine with TIL.
OUTLINE: This is a multicenter study. Patients are stratified according to center, tumor infiltrating lymphocyte (TIL) dose (low vs high), and medical condition suitable for interferon alfa (IFN-A)/interleukin-2 (IL-2) (yes vs no). Patients are assigned to one of two treatment regimens based on entry criteria. Regimen A (preferred): Patients meeting the preferred entry criteria receive IFN-A subcutaneously on days 1-4, TIL expanded in vitro with IL-2 IV on day 5, and IL-2 IV continuously over 72 hours following TIL infusion. Regimen B: All other patients receive TIL infusion once followed by oral cimetidine every 6 hours for 4 weeks. Treatment repeats in both regimens every 3-6 weeks in the absence of disease progression and according to TIL availability. Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 20-30 patients with melanoma and 20-30 patients with renal cell carcinoma will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologic evidence of any type of cancer with metastases Melanoma or renal cell cancer preferred No active brain metastasis Tumor infiltrating lymphocytes must be available Measurable or evaluable disease preferred
PATIENT CHARACTERISTICS: Age: 18 and over (under 75 preferred) Performance status: ECOG 0-3 (ECOG 0 or 1 preferred) Hematopoietic: (preferred) WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% (transfusion allowed) Hepatic: (preferred) Bilirubin less than 2.0 mg/dL PT/PTT normal Renal: (preferred) Creatinine less than 2.0 mg/dL Cardiovascular: (preferred) At least 6 months since prior myocardial infarction No congestive heart failure, cardiac arrhythmia, or hypertension requiring medication Pulmonary: (preferred) pO2 at least 60 mm Hg Reasonable respiratory reserve No supplemental oxygen requirement Not dyspneic at rest Other: No chronic auto-coagulation (preferred) No active infection No chronic underlying immunodeficiency disease (including HIV, hepatitis B) No known autoimmune disease Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (7 days since stereotactic radiosurgery) Surgery: At least 4 weeks since prior surgery to control brain metastases No prior organ transplantation
Contacts and Locations| United States, California | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| Study Chair: | Robert O. Dillman, MD, FACP | Cancer Biotherapy Research Group |
More Information
Additional Information:
Publications:
| Responsible Party: | Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian |
| ClinicalTrials.gov Identifier: | NCT00002733 History of Changes |
| Other Study ID Numbers: | CDR0000064631, CBRG-9510, NBSG-9510, NCI-V96-0835 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Hoag Memorial Hospital Presbyterian:
|
stage IV renal cell cancer stage IV melanoma unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Carcinoma, Renal Cell Kidney Neoplasms Melanoma Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Neuroendocrine Tumors Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferons Aldesleukin Cimetidine Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013