Interleukin-2 and Stem Cell Factor in Treating Patients With AIDS or AIDS-Related Cancer

NCT ID: NCT00058045

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Lymphoma

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

recombinant human stem cell factor

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Zale P. Bernstein, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

RPCI-RP-9911

Identifier Type: -

Identifier Source: secondary_id

RP 99-11

Identifier Type: -

Identifier Source: org_study_id