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Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

Phase 1
18 Years
Not Enrolling
Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Other Plasma Cell Dyscrasia (Waldenstrom, Amyloidosis), Leukemia

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Trial Information

Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

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%

- Age >18

- 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

- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

5 Years

Safety Issue:


Principal Investigator

Kenneth R Meehan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

January 2003

Completion Date:

April 2011

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Hodgkin's Disease
  • Multiple Myeloma
  • Other Plasma Cell Dyscrasia (Waldenstrom, Amyloidosis)
  • Leukemia
  • Autologous Peripheral Blood Stem Cell Transplant
  • IL-2
  • GM-CSF
  • Amyloidosis
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Paraproteinemias



Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756