Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: aldesleukin Biological: filgrastim Drug: busulfan Drug: cyclophosphamide Drug: etoposide Drug: melphalan Procedure: peripheral blood stem cell transplantation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | High Dose Chemotherapy And Autologous Peripheral Blood Stem Cell Rescue For High Risk Acute Leukemia |
| Study Start Date: | March 1999 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the efficacy of busulfan, cyclophosphamide, and etoposide followed by autologous peripheral blood stem cell transplantation and interleukin-2 in patients with high-risk acute leukemia.
- Determine the efficacy of immunomodulatory therapies in terms of relapse-free survival of these patients treated with this regimen.
- Determine the hematopoietic reconstitution, relapse, and survival of these patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed acute leukemia
High-risk due to any of the following:
- Cytogenetic abnormalities involving 5q, 7q, 8q, 11q23, or t(9;22)
- WBC greater than 100,000/mm3
- Prior myelodysplastic syndrome
- Complete remission (CR) lasting less than 12 months
- 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
- Second and third CR allowed
- Ineligible for higher priority national or institutional study or allogeneic peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin less than 1.5 times normal
- SGOT or SGPT less than 1.5 times normal
Renal:
- Creatinine less than 1.5 times normal
Cardiovascular:
- LVEF at least 45% if receiving cyclophosphamide
- Normal electrocardiogram OR
- Approval by cardiologist
Pulmonary:
- DLCO less than 60% predicted OR
- Approval by pulmonologist
Other:
- Not pregnant or nursing
- No concurrent illness that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States, 10032 | |
| Study Chair: | Charles S. Hesdorffer, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00008190 History of Changes |
| Other Study ID Numbers: | CDR0000068386, CPMC-IRB-8872, CPMC-CAMP-27, NCI-G00-1889 |
| Study First Received: | January 6, 2001 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia in remission |
adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission secondary acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Neoplasms by Histologic Type Neoplasms Busulfan Cyclophosphamide Melphalan Aldesleukin Etoposide Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Myeloablative Agonists Antirheumatic Agents Antineoplastic Agents, Phytogenic Adjuvants, Immunologic Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 21, 2013