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

Primary Purpose

Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GM-CSF
IL-2
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Autologous Peripheral Blood Stem Cell Transplant, IL-2, GM-CSF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IL-2 and GM-CSF for Mobilization

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Will immune-mobilized stem cell products be well tolerated once infused into patients and will engraft normally following high-dose chemotherapy and APBSCT.

Full Information

First Posted
August 4, 2009
Last Updated
April 23, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00952237
Brief Title
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
Official Title
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Other Plasma Cell Dyscrasia (Waldenstrom, Amyloidosis), Leukemia
Keywords
Autologous Peripheral Blood Stem Cell Transplant, IL-2, GM-CSF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IL-2 and GM-CSF for Mobilization
Arm Type
Experimental
Arm Description
Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF
Intervention Type
Drug
Intervention Name(s)
GM-CSF
Intervention Description
GM-CSF (Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor) The dose and duration of GM-CSF (7.5 mcg/kg/day) was selected. If used alone, this dose and duration would result in effective mobilization. GM-CSF will be started on Day #7 and will continue until completion of leukapheresis. G-CSF will be started (5mcg/kg/d) on Day #7 and will be given each morning. G-CSF will continue until completion of leukapheresis.
Intervention Type
Drug
Intervention Name(s)
IL-2
Intervention Description
IL-2 dose escalation: IL-2 will be administered as a single daily subcutaneous injection each evening until completion of leukapheresis. Escalation of the dose of IL-2 will be performed using the below schema with the following levels. Patients will be started on Level 1. (Level 0 is included since, if toxicity is meet in Level 1, the dose will be decreased to Level 0). Level 0 - 3 x 105 i.u./m2/day for 11 days Level 1 - 6 x 105 i.u./m2/day for 11 days Level 2 - 1 x 106 i.u. /m2/day for 11 days as above Level 3 - 1.5 x 106 i.u. /m2/day for 11 days as above Level 4 - 2 x 106 i.u. /m2/day for 11 days as above
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Will immune-mobilized stem cell products be well tolerated once infused into patients and will engraft normally following high-dose chemotherapy and APBSCT.
Time Frame
5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth R Meehan, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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

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