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

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Lymphoma

Treatments

Biological: aldesleukin

Biological: recombinant human stem cell factor

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00058045

RP 99-11

RPCI-RP-9911

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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