Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: aldesleukin Biological: recombinant human stem cell factor |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of Low-Dose Subcutaneous Interleukin 2 (IL-2) And Stem Cell Factor (r-metHuSCF) For Patients With AIDS And AIDS-Associated Malignancy |
| Enrollment: | 1 |
| Study Start Date: | August 2002 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the safety and toxicity of low-dose interleukin-2 and stem cell factor in patients with AIDS or AIDS-related malignancies.
- Determine the immune status of patients treated with this regimen.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
- Opportunistic infection
- Opportunistic malignancy (excluding CNS involvement)
- CD4 T-cell count less than 200/mm^3 (but currently greater than 20/mm^3)
- Receiving antiretroviral therapy
No concurrent Kaposi's sarcoma
- Prior Kaposi's sarcoma in complete response allowed
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count greater than 1,000/mm^3*
- Hemoglobin at least 10 g/dL*
- Platelet count greater than 50,000/mm^3* NOTE: *Transfusions and growth factors allowed in order to increase or maintain counts
Hepatic
- No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices
- Bilirubin no greater than 2 mg/dL
- INR no greater than 1.5
Renal
- Not specified
Cardiovascular
- No prior angioedema
- No uncontrolled hypertension (i.e., diastolic blood pressure greater than 115 mmHg)
- No unstable angina
- No New York Heart Association class III or IV heart disease
- No congestive heart failure
- No coronary angioplasty within the past 6 months
- No myocardial infarction within the past 6 months
- No uncontrolled atrial or ventricular cardiac arrhythmia
Pulmonary
- No history of seasonal or recurrent asthma within the past 10 years
- No concurrent asthmatic symptoms (e.g., wheezing) related to a current respiratory tract infection
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
- Fevers due to B symptoms allowed
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior or concurrent CNS malignancy
- No poorly controlled diabetes
- No other significant nonmalignant disease
- No other malignancy except those in stable partial response or stable complete response (no evidence of progressive disease for at least 8 weeks after therapy for the malignancy)
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Hematopoietic in Patient Characteristics
- No prior stem cell factor
- No concurrent interleukin-11 for thrombocytopenia
Chemotherapy
- No concurrent chemotherapy for malignancy
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No concurrent enrollment on any other protocol utilizing an investigational drug
- No concurrent beta adrenergic blocking agents
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital - Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Study Chair: | Zale P. Bernstein, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00058045 History of Changes |
| Other Study ID Numbers: | RP 99-11, RPCI-RP-9911 |
| Study First Received: | April 7, 2003 |
| Last Updated: | January 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Roswell Park Cancer Institute:
|
AIDS-related peripheral/systemic lymphoma |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome Lymphoma HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Aldesleukin Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 18, 2013