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Sponsored by: |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00016055 |
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining biological therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of biological therapy combined with temozolomide in treating patients who have metastatic melanoma.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: lymphokine-activated killer cells Drug: temozolomide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Interleukin 12-Primed Activated T Cells As Therapy For Patients With Metastatic Melanoma (Phase I) |
Estimated Enrollment: | 18 |
Study Start Date: | November 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of interleukin-12-primed activated T cells (12ATC).
Patients undergo leukopheresis on days 1-3 until adequate peripheral blood mononuclear cells (PBMC) are obtained. The PBMC are treated in vitro over 2 weeks with monoclonal antibody anti-CD3, interleukin-2, and interleukin-12 to form 12ATC.
Patients receive oral temozolomide on days 15-19 and 43-47 and 12ATC IV over 15-30 minutes on days 22, 25, 29, 32, 36, 39, 50, 53, 57, 60, 64, and 67 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of 12ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 patients experience dose-limiting toxicity.
Patients are followed weekly for 2 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed metastatic melanoma
Must meet one of the following criteria:
At least 1 documented site of bidimensionally measurable disease by MRI or CT scan
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Wisconsin | |
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | |
Milwaukee, Wisconsin, United States, 53215 |
Study Chair: | John P. Hanson, MD | Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center |
Study ID Numbers: | CDR0000068590, STLMC-IMM-0002, NCI-V01-1657 |
Study First Received: | May 6, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00016055 |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Interleukin-12 Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Nevus Temozolomide Recurrence Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Neoplasms, Nerve Tissue Nevi and Melanomas Antineoplastic Agents, Alkylating Alkylating Agents Pharmacologic Actions |