Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic Cancer
This study has been completed.
Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00003243
First received: November 1, 1999
Last updated: March 9, 2010
Last verified: March 2010
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. White blood cells from donors may be able to kill cancer cells in patients who have hematologic cancer that has recurred following bone marrow transplantation.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus infusion of donated white blood cells in treating patients who have hematologic cancer that has recurred after bone marrow transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: aldesleukin Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: etoposide Drug: pegylated liposomal doxorubicin hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Trial of Combined Chemotherapy and Donor Lymphocyte Infusion for Aggressive Hematologic Malignancies in Relapse After Allogeneic Bone Marrow Transplantation |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Bone Marrow Transplantation
Cancer
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Aldesleukin
Etoposide phosphate
Filgrastim
Lenograstim
Granulocyte colony-stimulating factor
U.S. FDA Resources
Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:
| Study Start Date: | January 1998 |
OBJECTIVES:
- Determine the maximum tolerated dose of doxorubicin HCl liposome when combined with etoposide, cyclophosphamide, and allogeneic donor lymphocyte infusion with or without interleukin-2 after allogeneic bone marrow transplantation in patients with relapsed or persistent aggressive hematologic malignancies.
OUTLINE: This is a partially randomized, dose-escalation study of doxorubicin HCl liposome (LipoDox).
Patients enter 1 of 4 cohorts.
- Cohort 1: Three to six patients receive induction comprising etoposide IV over 1 hour on days 1-3, cyclophosphamide IV over 1-2 hours on day 8, and allogeneic donor lymphocyte infusion on day 10. Filgrastim (G-CSF) is administered subcutaneously (SC) or IV daily beginning on day 10 and continuing until blood counts recover.
- Cohort 2: In the absence of dose-limiting toxicity (DLT) on cohort 1, 3-6 patients receive treatment as in cohort 1 and LipoDox IV over 2 hours on day 1.
Cohort 3: In the absence of DLT on cohort 2, 3-6 patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive treatment as in cohort 1 plus a higher dose of LipoDox IV over 2 hours on day 1.
- Arm II: Patients receive treatment as in cohort 1 and interleukin-2 (IL-2) SC on days 10-12.
If DLT is reached on cohort 2, 3-6 patients receive treatment as in arm II.
- Cohort 4: In the absence of DLT on arms I and II, patients receive treatment as in cohort 1, LipoDox as in arm I, and IL-2 as in arm II.
Cohorts of 3-6 patients receive escalating doses of LipoDox until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 12-18 months.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of relapsed or persistent acute leukemia, myelodysplasia, aggressive non-Hodgkin's lymphoma (NHL), or chronic myeloid leukemia in transformed phase (accelerated phase or blast crisis) after allogeneic bone marrow transplantation (BMT)
- Aggressive NHL defined as diffuse mixed, diffuse large cell, diffuse small noncleaved cell, and lymphoblastic histologies
- No active acute graft versus host disease (GVHD) or extensive chronic GVHD
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- More than 4 weeks
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No severe psychiatric illness or mental deficiencies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- At least 6 months since prior allogeneic BMT
- No other concurrent interleukin-2
- No other concurrent immunomodulatory medication (e.g., interferon)
Chemotherapy:
- Not specified
Endocrine therapy:
- No concurrent steroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent immunosuppressive medication (e.g., cyclosporine) for GVHD
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003243
Locations
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
| Study Chair: | Ephraim J. Fuchs, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003243 History of Changes |
| Other Study ID Numbers: | CDR0000066119, J9743, P30CA006973, JHOC-97112101, NCI-V98-1387 |
| Study First Received: | November 1, 1999 |
| Last Updated: | March 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
recurrent childhood acute lymphoblastic leukemia recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia acute undifferentiated leukemia recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma secondary acute myeloid leukemia previously treated myelodysplastic syndromes recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma childhood chronic myelogenous leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable childhood myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Cyclophosphamide Aldesleukin Doxorubicin Etoposide Lenograstim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
ClinicalTrials.gov processed this record on June 18, 2013