RATIONALE: Velafermin may help prevent symptoms of mucositis, or mouth sores, in patients receiving chemotherapy and/or total-body irradiation followed by an autologous stem cell transplant. It is not yet known whether velafermin is more effective than placebo in preventing mucositis.

PURPOSE: This randomized phase II trial is studying velafermin to see how well it works compared to placebo in preventing mucositis in patients receiving chemotherapy and/or total-body irradiation followed by an autologous stem cell transplant.

OBJECTIVES: Primary

• Compare the efficacy of velafermin (CG53135-05) vs placebo, in terms of decreasing the incidence of grade 3 or 4 oral mucositis, in patients receiving a conditioning regimen comprising high-dose myeloablative chemotherapy and/or total-body irradiation followed by autologous hematopoietic stem cell transplantation.

Secondary

• Compare the safety of these regimens in these patients.
• Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and prior treatment regimen (total-body irradiation [TBI] vs chemotherapy without TBI).

Patients receive a conditioning regimen comprising high-dose melphalan, busulfan, or etoposide and/or TBI between days -14 to -2. Patients undergo autologous hematopoietic stem cell transplantation on day 0. Patients are then randomized to 1 of 4 treatment arms.

• Arm I: Patients receive a placebo IV over 15 minutes once on day 1.
• Arm II: Patients receive velafermin (CG53135-05) IV over 15 minutes once on day 1.
• Arm III: Patients receive CG53135-05 as in arm II at a higher dose.
• Arm IV: Patients receive CG53135-05 as in arm II but at a higher dose than arm III. After completion of study treatment, patients are followed at approximately days 15, 30, and 90.

PROJECTED ACCRUAL: A total of 200 patients (50 per treatment arm) will be accrued for this study within 1 year.

DISEASE CHARACTERISTICS:

• Eligible for and able to tolerate autologous hematopoietic stem cell transplantation (AHSCT)
• Receiving a conditioning regimen comprising high-dose melphalan, busulfan, or etoposide AND/OR total-body irradiation

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,500/mm^3* NOTE: *Prior to initiating high-dose chemotherapy and/or radiotherapy

Hepatic

• AST and ALT < 2.5 times upper limit of normal (ULN)*
• Bilirubin < 1.5 times ULN*
• No hepatitis B or C positivity NOTE: *Prior to initiating high-dose chemotherapy and/or radiotherapy

Renal

• Creatinine based on the institution''''s protocol for stem cell transplantation* NOTE: *Prior to initiating high-dose chemotherapy and/or radiotherapy

Immunologic

• No AIDS
• No known hypersensitivity to recombinant protein therapy
• No history of sensitivity or allergy to E. coli-derived products
• No untreated symptomatic dental infection

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Weight > 33 kg but < 125 kg
• No active medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY: Biologic therapy

• More than 30 days since prior velafermin (CG53135-05), sargramostim (GM-CSF), or palifermin
• No concurrent GM-CSF or palifermin for the treatment of oral mucositis (OM)

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• Not specified

Other

• More than 30 days since prior investigational drugs
• No concurrent nystatin
• No other concurrent investigational drugs for the treatment of OM