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Sponsors and Collaborators: |
Massey Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006022 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining bryostatin 1 with interleukin-2 may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of interleukin-2 plus bryostatin 1 in treating patients who have melanoma or kidney cancer that cannot be removed during surgery.
Condition | Intervention | Phase |
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Kidney Cancer Melanoma (Skin) |
Biological: aldesleukin Drug: bryostatin 1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control |
Official Title: | Phase IA/IB Trial of Modulation of the Biological Response to Interleukin-2 (IL-2) With Bryostatin 1 (BRYO; NSC 339555) |
Study Start Date: | September 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind study. Patients are randomized to one of three bryostatin 1 dose levels.
Patients receive interleukin-2 subcutaneously daily on days 1-5 and bryostatin 1 IV over 1 hour on day 1 weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cutaneous or mucosal melanoma or renal cell carcinoma
No known uncontrolled CNS metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, New Hampshire | |
Norris Cotton Cancer Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, Virginia | |
Massey Cancer Center | |
Richmond, Virginia, United States, 23219 |
Study Chair: | John D. Roberts, MD | Massey Cancer Center |
Study ID Numbers: | CDR0000068034, MCV-MCC/CCHR-9910-2A, NCI-T99-0049 |
Study First Received: | July 5, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00006022 History of Changes |
Health Authority: | United States: Federal Government |
stage III renal cell cancer stage IV renal cell cancer recurrent renal cell cancer |
stage III melanoma stage IV melanoma recurrent melanoma |
Urinary Tract Neoplasm Immunologic Factors Urogenital Neoplasms Urologic Neoplasms Melanoma Renal Cancer Anti-Retroviral Agents Urologic Diseases Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Kidney Diseases Analgesics Kidney Cancer |
Anti-HIV Agents Adjuvants, Immunologic Bryostatin 1 Antiviral Agents Recurrence Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Aldesleukin Interleukin-2 Analgesics, Non-Narcotic Carcinoma, Renal Cell Peripheral Nervous System Agents Nevus Adenocarcinoma |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Urologic Neoplasms Melanoma Neoplasms by Site Anti-Retroviral Agents Urologic Diseases Sensory System Agents Kidney Neoplasms Neoplasms, Germ Cell and Embryonal Therapeutic Uses |
Nevi and Melanomas Analgesics Kidney Diseases Anti-HIV Agents Neoplasms by Histologic Type Adjuvants, Immunologic Bryostatin 1 Antiviral Agents Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Interleukin-2 |