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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-RP-9911 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill cancer cells. Stem cell factor may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of cancer therapy.
PURPOSE: Phase I trial to study the effectiveness of combining interleukin-2 with stem cell factor in treating patients who have AIDS or AIDS-related cancer.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of stem cell factor.
Patients receive interleukin-2 (IL-2) subcutaneously (SC) six days a week and stem cell factor SC three times a week for 8 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of stem cell factor 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. Once the MTD is determined, an additional cohort of 3 patients receives treatment at the MTD.
Patients are followed every 2 weeks for 1 month.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| recombinant human stem cell factor | Biological |
DISEASE CHARACTERISTICS:
Diagnosis of HIV-1 by ELISA, Western blot, polymerase chain reaction, or other documentation
Must have had 1 of the following AIDS-defining illnesses:
Receiving antiretroviral therapy
No concurrent Kaposi's sarcoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Immunologic
No prior positive allergy test (skin or radioallergosorbent test) for insect venoms
No known allergy to E. coli-derived products
No prior anaphylactic events manifested by disseminated urticaria, laryngeal edema, and/or bronchospasm
Drug allergies manifested solely by rash and/or urticaria allowed
No recurrent urticaria (isolated episode of urticaria allowed)
No other active uncontrolled infection (including one with current symptoms of bronchoconstriction)
No fever of 38.2° C or higher
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Zale P. Bernstein, MD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States | ||
| Arthur G. James Cancer Hospital - Ohio State University |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D019089 | Stem Cell Factor |
| ID | Term |
|---|---|
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Columbus |
| Ohio |
| 43210 |
| United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |