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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

Phase 1
18 Years
Not Enrolling

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Trial Information

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


- 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.

Inclusion Criteria


- Diagnosis of HIV-1 by ELISA, Western blot, polymerase chain reaction, or other

- 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



- 18 and over

Performance status

- Karnofsky 80-100%

Life expectancy

- Not specified


- 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


- No major hepatic dysfunction evidenced by encephalopathy, ascites, or varices

- Bilirubin no greater than 2 mg/dL

- INR no greater than 1.5


- Not specified


- 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


- 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


- 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

- No fever of 38.2° C or higher

- Fevers due to B symptoms allowed


- 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)


Biologic therapy

- See Hematopoietic in Patient Characteristics

- No prior stem cell factor

- No concurrent interleukin-11 for thrombocytopenia


- No concurrent chemotherapy for malignancy

Endocrine therapy

- Not specified


- Not specified


- Not specified


- No concurrent enrollment on any other protocol utilizing an investigational drug

- No concurrent beta adrenergic blocking agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Zale P. Bernstein, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Federal Government

Study ID:

RP 99-11



Start Date:

August 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • AIDS-related peripheral/systemic lymphoma
  • Acquired Immunodeficiency Syndrome
  • Lymphoma



Roswell Park Cancer Institute Buffalo, New York  14263
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210