Combination Chemotherapy in Hodgkin's Disease or Non-Hodgkin's Lymphoma Not Responding to Previous Treatment

• Status: Completed
• Trial end date: 2009-02-10
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have Hodgkin's disease or non-Hodgkin's lymphoma that has not responded to previous treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborator: Eli Lilly and Company
• Treatments: BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed Hodgkin's disease OR

• Histologically or cytologically confirmed aggressive non-Hodgkin's lymphoma (NHL) of B-cell origin (including immunoblastic, anaplastic large cell, mediastinal large B-cell, or T-cell rich B-cell NHL)

• No prior diagnosis of low-grade NHL

• No histologic evidence of transformation from indolent to aggressive histology

• Bidimensionally measurable disease that is clinically or radiologically documented

• Bone lesions not considered bidimensionally measurable

• Lymph nodes at least 1.5 cm by 1.5 cm OR

• Other non-nodal lesions at least 1 cm by 1 cm

• Recurrent or refractory to 1 prior chemotherapy regimen (excluding gemcitabine and cisplatin)

• No known CNS involvement 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:

• 16 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST or ALT no greater than 2.5 times ULN

Renal:

• Creatinine less than 1.6 mg/dL

Cardiovascular:

• No significant cardiac dysfunction or cardiovascular disease

Other:

• HIV negative

• No other concurrent or prior malignancy within the past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix

• No other serious illness or medical condition that would preclude study

• No active uncontrolled bacterial, fungal, or viral infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior stem cell transplantation

• No concurrent monoclonal antibody therapy

• No concurrent growth factors during the first course of study

Chemotherapy:

• See Disease Characteristics

• At least 4 weeks since prior IV chemotherapy

• No prior cisplatin or gemcitabine

• No prior high-dose chemotherapy

• No other concurrent cytotoxic therapy

Endocrine therapy:

• No concurrent corticosteroids, except for physiologic replacement

Radiotherapy:

• No prior radiotherapy to more than 25% of functioning bone marrow

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• At least 2 weeks since prior major surgery

Other:

• No other concurrent anti-cancer therapy or experimental therapy