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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112476 |
RATIONALE: Drugs used in chemotherapy, such as temsirolimus and bryostatin 1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of temsirolimus when given together with bryostatin 1 in treating patients with unresectable or metastatic solid tumors.
Condition | Intervention | Phase |
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Kidney Cancer Melanoma (Skin) Unspecified Adult Solid Tumor, Protocol Specific |
Drug: bryostatin 1 Drug: temsirolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Intravenous CCI-779 in Combination With Bryostatin-1 in Solid Tumors (10038414) |
Estimated Enrollment: | 24 |
Study Start Date: | March 2005 |
Estimated Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of temsirolimus.
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, 15, and 22 and temsirolimus IV over 30 minutes once on days 8, 15, and 22 during course 1. On subsequent courses patients receive bryostatin 1 and temsirolimus once on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study within 4-8 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor, including melanoma or renal cell carcinoma
Metastatic or unresectable disease
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
More than 3 weeks since prior major surgery, including nephrectomy
Other
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19111-2497 |
Study Chair: | Naomi S. Balzer-Haas, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000432955, FCCC-04037, NCI-5785 |
Study First Received: | June 2, 2005 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00112476 |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific recurrent melanoma stage IV melanoma recurrent renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Bryostatin 1 Renal cancer Kidney cancer Urologic Neoplasms Recurrence Melanoma Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Urologic Diseases |
Kidney Neoplasms Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Carcinoma, Renal Cell Neuroepithelioma Nevus Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Adjuvants, Immunologic Nevi and Melanomas Pharmacologic Actions |