Overview
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
2011-12-01
2011-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research InstituteCollaborator:
National Cancer Institute (NCI)Treatments:
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Mesna
Topotecan
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed non-Hodgkin's lymphoma
- No lymphoblastic lymphoma
- Under 55 years of age:
- Intermediate and high grade or aggressive disease that has relapsed and/or
failed at least 2 salvage chemotherapy regimens OR
- Failed to achieve complete response after first line induction chemotherapy
and failed at least 1 salvage chemotherapy regimen
- Low grade or indolent disease that has relapsed or failed to achieve
complete response after first line induction chemotherapy and failed more
than 2 salvage chemotherapy regimens
- 55 years of age and over:
- Intermediate and high grade or aggressive disease that has relapsed and/or
failed to achieve complete response after first line induction chemotherapy
- Low grade or indolent disease that has relapsed or failed to achieve
complete response after first line induction chemotherapy OR
- Histologically confirmed Hodgkin's lymphoma
- Under 55 years of age:
- Received at least 2 prior salvage chemotherapy regimens
- 55 years of age and over:
- Stage III or IV disease that has relapsed or failed to achieve remission
after combination induction chemotherapy
- Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence
in radiation field, B symptoms, or liver or bone marrow involvement)
- No active leptomeningeal involvement or severe symptomatic CNS disease
- Prior CSF tumor involvement allowed if asymptomatic and no evidence of disease on
lumbar puncture or no tumor involvement on MRI of the brain
- Solid tumors and brain metastases allowed
- No evidence of disease by MRI and physical exam following optimal prior surgery
and/or radiotherapy AND
- At least 3 months since prior radiotherapy NOTE: 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:
- 18 to 64
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL*
- SGOT or SGPT no greater than 2.5 times normal*
- No severe hepatic dysfunction NOTE: *Unless due to primary malignancy
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No severe cardiac dysfunction
- Ejection fraction at least 50% by MUGA scan
- Essential hypertension controlled by medication allowed
Pulmonary:
- DLCO at least 50% of normal OR
- No symptomatic obstructive or restrictive disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No active infection
- HIV negative
- No insulin dependent diabetes mellitus
- No uncompensated major thyroid or adrenal dysfunction
- No significant skin breakdown from tumor or other disease
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- Prior doxorubicin or daunorubicin allowed if total dose no greater than 450 mg/m2
- No prior topotecan
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Other:
- No concurrent nitroglycerin preparations for angina pectoris
- No concurrent antiarrhythmic drugs for major ventricular arrhythmias