NCT00952237CompletedPhase 1
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
Dartmouth-Hitchcock Medical Center1 site in 1 country13 target enrollmentStarted: January 2003Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Can IL-2 be administered with GM-CSF to efficiently mobilize autologous peripheral blood stem cells. This study will determine the maximum tolerated dose of IL-2 and the optimal biological dose with GM-CSF for stem cell mobilization.
Study Overview
Brief Summary
We postulate that the combination of IL-2 and GM-CSF immunotherapy will efficiently mobilize autologous peripheral blood stem cells and activated immune effector cells in patients with a hematologic malignancy. These activated effector cells will improve the immune function of the graft. These hypotheses will be tested using this proposed clinical trial to mobilize autologous peripheral blood stem cells pre-transplantation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients must have pathologic diagnosis of one of the following malignancies: Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma or other plasma cell dyscrasia (Waldenstrom, Amyloidosis), Leukemia (AML, ALL, CLL)
- •Prior Treatment: > 2 weeks prior to initiation of therapy.
- •Performance Status: Karnofsky > 70%
- •Life Expectancy > 4 months
- •Bone Marrow: bone marrow biopsy and aspirate
- •Blood counts: The patient must have adequate bone marrow function, i.e. a total WBC of > 2,000/ul, a Hgb of > 7 mg/dl, and a platelet count of > 50,000/ul, unless this abnormality is believed to be due to the underlying disease.
- •Pulmonary function tests: DLCO > 55% predicted.
- •Cardiac: Left ventricular ejection fraction of > 40% by radionuclide scan or echocardiography.
- •Liver function tests (bilirubin, alkaline phosphatase, and SGOT/SGPT) < 3 x normal (unless believed to be elevated due to disease).
- •No significant co-morbid medical or psychiatric illness that would significantly compromise the patient's clinical care and chances of survival.
- •Informed Consent: Informed consent must be signed prior to the treatment. Patients must be aware of the neoplastic nature of their disease and willingly consent after being informed of the procedure to be followed, the nature of the therapy, alternatives, potential benefits, side effects, risks and discomforts. The patient is not deemed eligible if there is any other serious medical or psychiatric illness that would prevent informed consent. (Human protection committee approval of this protocol and a consent form is required.)
Exclusion Criteria
- •Medical, social, or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy.
- •Evidence on physical exam, LP, CT, or MRI scans of CNS involvement with malignancy.
- •Uncontrolled or severe cardiovascular disease, including recent (< 6 months) myocardial infarction, congestive heart failure, angina (symptomatic despite optimal medical management), life-threatening arrhythmia, or hypertension or clinically significant obstructive/restrictive pulmonary disease.
- •Serology positive for HIV
- •History of seizures.
- •Concurrent or expected need for therapy with systemic corticosteroids (since systemic steroids may suppress the effects of IL-2).
- •Current and clinically significant pleural effusion, pericardial effusion, or ascites.
- •Positive pregnancy test or presence of lactation.
- •Uncontrolled active infection.
- •Documented hypersensitivity to any of the drugs used in the protocol.
- •No concomitant, ongoing malignancy that is life-threatening, based on PI's evaluation
Arms & Interventions
IL-2 and GM-CSF for Mobilization
Experimental
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
Intervention: GM-CSF (Drug)
IL-2 and GM-CSF for Mobilization
Experimental
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
Intervention: IL-2 (Drug)
Outcomes
Primary Outcomes
Can IL-2 be administered with GM-CSF to efficiently mobilize autologous peripheral blood stem cells. This study will determine the maximum tolerated dose of IL-2 and the optimal biological dose with GM-CSF for stem cell mobilization.
Time Frame: 5 Years
Secondary Outcomes
- Will immune-mobilized stem cell products be well tolerated once infused into patients and will engraft normally following high-dose chemotherapy and APBSCT.(5 Years)
Investigators
Kenneth Meehan
Director, Bone Marrow Transplant Program
Dartmouth-Hitchcock Medical Center
Study Sites (1)
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