Lymphoma Clinical Trial
Official title:
Dose Escalation of VP-16 With Cyclophosphamide and Total Body Irradiation as Preparative Regimen for Autologous Transplantation for High-Grade Lymphoma and Acute Lymphoblastic Leukemia
Verified date | June 2012 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in
chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
die. Peripheral stem cell transplantation may allow doctors to give higher doses of
chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy and chemotherapy
plus peripheral stem cell transplantation in treating patients who have high-grade lymphoma
or acute lymphoblastic leukemia.
Status | Completed |
Enrollment | 6 |
Est. completion date | July 2003 |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 65 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically proven high grade lymphoma (including small
noncleaved) by lymph node biopsy OR acute lymphoblastic leukemia (ALL) by bone marrow
aspiration and biopsy Lymphoblastic lymphoma: First remission allowed if elevated LDH or
stage IV disease Early relapse allowed Must have CT of abdomen, pelvis, and chest obtained
within 4-6 weeks prior to enrollment Measurable disease not required First remission
transplantation is encouraged if poor prognostic indicators were present at diagnosis and
the objective parameter of measure is long term disease free survival ALL: Patients with
inaspirable bone marrow aspirate smears eligible if diagnosis confirmed by bone marrow
core biopsy Any complete remission allowed All patients in relapse should have attempted
reinduction of remission Patients in early relapse (defined as no greater than 20%
lymphoblasts in bone marrow) eligible if bone marrow harvested while in remission (less
than 5% blasts) Must be eligible for total body irradiation Negative CSF cytology within
4-6 weeks of enrollment No active CNS lymphoma or leukemia A new classification scheme for
adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or
"aggressive" lymphoma will replace the former terminology of "low", "intermediate", or
"high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: Physiologic age 65 and under for autologous peripheral blood stem cell transplantation If age 55 and under, priority should be given to finding an allogeneic donor Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 40% by MUGA scan or clearance by a cardiologist No myocardial infarction within the past 6 months No active angina pectoris Pulmonary: FEV1 and DLCO at least 50% predicted Other: No active serious psychiatric or medical illness that would preclude administration of high dose chemotherapy HIV negative Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy greater than 25 Gy to the craniospinal axis Surgery: See Disease Characteristics |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Cancer Institute (NCI) |
United States,
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