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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-01-C-0121 | |||
| NCI-1035 |
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RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to stimulate the immune system and stop cancer cells from growing. Biological therapy may be an effective treatment for metastatic melanoma and metastatic kidney cancer.
PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in treating patients who have metastatic melanoma or metastatic kidney cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of CD40-ligand when combined with fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer.
OUTLINE: This is a dose-escalation study of CD40-ligand. Patients receive fixed-dose flt3 ligand subcutaneously (SC) daily on days 1-14 and CD40-ligand SC daily on days 12-16. Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3 to 6 patients receive escalating doses of CD40-ligand until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2 (IL-2) standard therapy.
PROJECTED ACCRUAL: A total of 5 patients were accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant CD40-ligand | Biological | |||
| recombinant flt3 ligand | Biological |
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer or melanoma Measurable disease
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and ALT less than 2.5 times normal Hepatitis B surface antigen negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major active medical illness of the cardiovascular system (e.g., cardiac ischemia, myocardial infarction, or cardiac arrhythmia) Pulmonary: No major active medical illness of the respiratory system (e.g., obstructive or restrictive pulmonary disease) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active systemic infections No history of autoimmune disorders HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No prior systemic flt3 ligand or CD40-ligand Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent systemic steroids Radiotherapy: Prior localized radiotherapy for renal cell cancer or melanoma allowed Surgery: Prior surgery for renal cell cancer or melanoma allowed
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Hwu, MD | NCI - Surgery Branch | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery Branch | Bethesda | Maryland | 20892 | United States |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D023201 | CD40 Ligand |
| C084881 | flt3 ligand protein |
| ID | Term |
|---|---|
| D008562 | Membrane Glycoproteins |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D048069 |
| Tumor Necrosis Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D008565 | Membrane Proteins |
| D001685 | Biological Factors |