Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
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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. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide |
| Study Start Date: | December 1999 |
OBJECTIVES:
- Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies.
- Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients.
- Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen.
OUTLINE: This is a dose-escalation study of cyclophosphamide.
Patients receive fludarabine IV over 1 hour on days -6 to -2; cyclophosphamide IV over 1 hour on days -6, -5, and 3; total body irradiation on day -1; and allogeneic bone marrow transplantation on day 0. Patients also receive tacrolimus IV or orally twice a day on days 4-50; oral mycophenolate mofetil on days 4-35; and filgrastim (G-CSF) subcutaneously or IV starting on day 4 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined.
Patients are followed at 2 and 6 months, at one year, and then annually thereafter.
PROJECTED ACCRUAL: At least 23 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Patients with any of the following diagnoses:
Chronic myelogenous leukemia
Chronic phase 1
- Failed prior interferon alfa therapy OR
- Relapsed after prior autologous stem cell transplantation
- Chronic phase 2
Acute leukemia
Standard risk
- Age over 60 years
- Complete remission 1 (CR1)
High risk
- High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy
- CR1
- Complete remission 2 or higher
Acute lymphocytic leukemia
- CR1 or higher
Myelodysplastic syndrome
- Untreated OR
- CR1
- Acute myeloid leukemia in CR1
Chronic lymphocytic leukemia
- Rai stage III or IV OR
- Received prior autologous stem cell transplantation
Multiple myeloma
- Stage II or III
- Stable or progressive disease after prior chemotherapy OR
- Received prior autologous stem cell transplantation
- Non-Hodgkin's Lymphoma
- Hodgkin's lymphoma
- Ineligible for or refused autologous or standard allogeneic bone marrow transplantation
- Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor
- Must have an HLA mismatched, related donor (3-5 out of 6)
PATIENT CHARACTERISTICS:
Age:
- 0.5 to 70
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin less than 3.1 mg/dL
Renal:
- Not specified
Cardiovascular:
- Left ventricular ejection fraction at least 35%
Pulmonary:
- FEV_1 and FVC at least 40% of predicted OR
- FEV_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy
Other:
- HIV negative
- No other debilitating medical or psychiatric illness that would preclude study compliance
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
- No prior transfusions from donor
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Ephraim J. Fuchs, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006042 History of Changes |
| Other Study ID Numbers: | CDR0000068057, J9966, P30CA006973, JHOC-J9966, JHOC-99110501, NCI-G00-1816 |
| Study First Received: | July 5, 2000 |
| Last Updated: | March 9, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
recurrent adult Hodgkin lymphoma Burkitt lymphoma refractory multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent childhood lymphoblastic lymphoma stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous 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 |
recurrent/refractory childhood Hodgkin lymphoma stage II adult lymphoblastic lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult lymphoblastic lymphoma |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Lymphoma, Large-Cell, Immunoblastic Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Bone Marrow Diseases Precancerous Conditions Lymphoma, Non-Hodgkin Cyclophosphamide Mycophenolate mofetil Fludarabine monophosphate Tacrolimus |
ClinicalTrials.gov processed this record on May 19, 2013