A Randomized Study of the Site for Growth Factor Injection for Patients Undergoing Autologous Stem Cell Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether or not the injection site of cytokines, or growth factors, has an effect on peripheral blood stem cell collection.

Detailed Description
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The purpose of this study is to determine the preferred injection site for G-CSF and GM-CSF, which are cytokines, or growth factors. The doctor may also choose to use these growth factors in combination with chemotherapy to increase the number of stem cells in the blood. Both options are established and are effective in increasing the number of stem cells in the blood. Patients will receive one shot under the skin twice a day for approximately 12-15 days after receiving chemotherapy through the time your cells are being collected. Patients will be randomly assigned to receive growth factors administered either to their abdomen or to their extremities. Both shots will always be given either in the abdomen or in the extremities.

Official Title
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A Phase II Single Institution Randomized Study Comparing Cytokine Administration Sites for Mobilization of Peripheral Hematopoietic Progenitor Cells for Patients Undergoing Autologous Hematopoietic Progenitor Cell Transplant

Conditions
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Cytokines

Intervention / Treatment
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* Drug: G-CSF, GM-CSF administered at extremities
* Drug: G-CSF and GMCSF administered at abdomen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing autologous peripheral blood stem cell transplant (PBSC) for relapsed/refractory Hodgkin's disease, non-Hodgkin's lymphoma, or patients with myeloma. All patients must meet criteria for transplantation. Exclusion Criteria: Patients with active, invasive/systemic fungal infection. Patients who are pregnant or lactating females. Patients with active CNS malignant disease or life expectancy limited by diseases other than the disease for which the patient is being transplanted. Also, patients cannot have known hypersensitivity to either G-CSF or GM-CSF.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Abdomen<br>These subjects will have their cytokine injections administered only to their abdomen. | Drug: G-CSF and GMCSF administered at abdomen<br>* Injection site Abdomen: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a BID schedule of G-CSF/GM-CSF until stem cell collection is complete.<br>* Other names: Neupogen, Leukine, growth factors;|
| Active Comparator: Extremities<br>The extremity arm will have their injections administered to their upper and/or lower extremities. | Drug: G-CSF, GM-CSF administered at extremities<br>* Injection site Extremities: G-CSF injections will commence on the day after completion of mobilization chemotherapy, at least 24 hours after completion of the last chemotherapy dose. On the seventh day of cytokine administration, GMCSF injections will be started, and patients will maintain a twice daily schedule of G-CSF/GM-CSF until stem cell collection is complete.<br>* Other names: Neupogen, Leukine, growth factors;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Total Number of CD34+ Cells Collected. |  | 4 days | 
| Number of Participants for Whom Target Number of CD34+ Cells Were Collected. | Target numbers of CD34+ cells for a single autologous transplant are typically at least 5.0 * 10^6 cells/kg, a cell dose that consistently results in rapid cell engraftment | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Days of Apheresis | the number of days of apheresis required to collect target numbers of CD34+ cells. | 7 days |