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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019942 |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a patient's white blood cells with interleukin-2 may stimulate them to kill tumor cells.
PURPOSE: This phase II trial is studying how well giving chemotherapy together with biological therapy works in treating patients with metastatic melanoma that has not responded to previous therapy.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Drug: aldesleukin Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Nonmyeloablative But Lymphocyte Depleting Regimen |
Estimated Enrollment: | 250 |
Study Start Date: | September 1999 |
Estimated Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Cohorts 1 and 2 (phase I): Experimental
Patients receive increasing doses of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 without IL-2.
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Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
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Cohort 3 (phase I): Experimental
Patients receive the maximum tolerated dose (MTD) of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 followed by low-dose IL-2 IV over 15 minutes every 8 hours on days 1-45 for 6 weeks.
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Drug: aldesleukin
Given IV
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
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Cohort 4 (phase I): Experimental
Patients receive the MTD of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 followed by high-dose IL-2 IV over 15 minutes every 8 hours on days 1-3.
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Drug: aldesleukin
Given IV
Drug: cyclophosphamide
Given IV
Drug: fludarabine phosphate
Given IV
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OBJECTIVES:
OUTLINE: This is a dose-escalation study of interleukin-2 (IL-2), cyclophosphamide, and fludarabine. Patients are stratified according to route of administration of cloned lymphocytes (IV vs intra-arterial).
Phase I (Closed to accrual effective 07/24/2001)
Nonmyeloablative preparative regimen and lymphocyte administration: Patients are assigned to 1 of 4 cohorts and receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 with or without IL-2.
All patients receive activated lymphocytes IV or intra-arterially over 20-30 minutes on day 0*. Patients with a predominant site of disease with an identifiable vascular supply to tumor(s) receive cells via intra-arterial infusion. Beginning 1-2 days after completion of lymphocyte infusion, some patients receive filgrastim (G-CSF) subcutaneously once daily until blood counts recover.
NOTE: *Day 0 is 1-4 days after completion of fludarabine administration.
Immunization: Patients are immunized with a peptide emulsified in Montanide ISA-51 once daily for 5 days and then weekly times 3 beginning on day 0**, depending on lymphocyte reactivity.
NOTE: **Immunization occurs on the same day as lymphocyte infusion
Phase II
NOTE: ***Patients ineligible to receive high-dose IL-2 due to the presence of cardiovascular or respiratory system illness may receive low-dose IL-2 SC daily on days 0-4, 7-11, 14-18, 21-25, 28-32, and 35-39.
Patients are followed at 3-4 weeks.
PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study. (Phase I closed to accrual effective 07/24/2001.)
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Patient Recruitment 866-820-4505 |
Study Chair: | Steven A. Rosenberg, MD, PhD | NCI - Surgery Branch |
Study ID Numbers: | CDR0000067331, NCI-99-C-0158, NCI-T99-0078 |
Study First Received: | July 11, 2001 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00019942 |
Health Authority: | Unspecified |
stage IV melanoma recurrent melanoma |
Neuroectodermal Tumors Aldesleukin Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma Fludarabine |
Fludarabine monophosphate Cyclophosphamide Nevus Recurrence Neuroendocrine Tumors Melanoma |
Antimetabolites Anti-Infective Agents Anti-HIV Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Antiviral Agents |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses Myeloablative Agonists Nevi and Melanomas Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |