Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CPMC-IRB-8872 | |||
| CPMC-CAMP-27 | |||
| NCI-G00-1889 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation and interleukin-2 in treating patients who have acute leukemia.
OBJECTIVES:
OUTLINE: Following a course of mobilization chemotherapy, patients receive priming therapy comprising filgrastim (G-CSF) and interleukin-2 through the completion of leukapheresis. Patients then receive oral busulfan 4 times daily on days -8 through -5, cyclophosphamide IV continuously on days -4 and -3, and etoposide IV over 2 hours on day -4. For patients unable to receive cyclophosphamide and etoposide, melphalan IV is administered instead on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are reinfused on day 0.
Patients then receive G-CSF daily beginning on day 0 and continuing until blood counts recover followed by interleukin-2 subcutaneously daily beginning at the completion of G-CSF therapy and continuing for 6 months.
Patients are followed weekly for 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 19-25 patients will be accrued for this study within 3-5 years.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| filgrastim | Biological | |||
| busulfan | Drug | |||
| cyclophosphamide | Drug | |||
| etoposide | Drug | |||
| melphalan | Drug | |||
| peripheral blood stem cell transplantation | Procedure |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed acute leukemia
High-risk due to any of the following:
No favorable cytogenetic parameters (e.g., t(15;17), inv16, or t(8;21))
CR following standard anti-leukemic therapy confirmed by bone marrow evaluation
Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles S. Hesdorffer, MD | Herbert Irving Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herbert Irving Comprehensive Cancer Center at Columbia University | New York | New York | 10032 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
Not provided
Not provided
| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D000069585 | Filgrastim |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008558 | Melphalan |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided