Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

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