Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Biological Therapy in Treating Patients With Solid Tumors or Lymphoma

NCT ID: NCT00027937

Last Updated: 2010-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2007-11-30

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapies such as interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have solid tumors or lymphoma.

Detailed Description

OBJECTIVES:

• Determine the toxicity of sargramostim (GM-CSF) and filgrastim (G-CSF)-mobilized interleukin-2(IL-2)-incubated autologous peripheral blood stem cells and sequential IL-2 in patients with solid tumors or lymphoma.
• Determine the ability of cyclophosphamide and paclitaxel followed by GM-CSF and G-CSF to mobilize adequate numbers of CD34+ cells and immune cells in these patients.
• Determine the time to neutrophil and platelet engraftment in patients treated with this regimen.
• Determine the overall and disease-free survival of patients treated with this regimen.

OUTLINE: Patients receive cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) alone on days 3-9 and GM-CSF and filgrastim (G-CSF) SC beginning on day 10 and continuing until leukapheresis is completed.

Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -8 to -6, melphalan IV on days -5 and -4, and thiotepa IV on days -3 and -2. Autologous peripheral blood stem cells (PBSC) are treated ex vivo with interleukin-2 (IL-2) on day -1. Patients undergo IL-2-treated autologous PBSC transplantation on day 0.

Beginning 4 hours after PBSC transplantation, patients receive IL-2 IV continuously for 5 days. IL-2 therapy repeats every 7 days for 4 courses.

Patients are followed on days 60-80, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 3 years.

Conditions

Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

filgrastim

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

busulfan

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

melphalan

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

thiotepa

Intervention Type: DRUG

bone marrow ablation with stem cell support

Intervention Type: PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• No pleural effusion, pericardial effusion, or ascites
• No T-cell lymphoma

PATIENT CHARACTERISTICS:

Age:

• Under 57

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 1.5 mg/dL (unless due to Gilbert's disease)
• SGOT or SGPT no greater than 2 times upper limit of normal
• Hepatitis B and C negative

Renal:

• Creatinine no greater than 2.0 mg/dL OR
• Creatinine clearance at least 60 mL/min

Cardiovascular:

• LVEF at least 50%
• No congestive heart disease
• No history of myocardial infarction within the past year
• No coronary artery disease
• No history of arrhythmia

Pulmonary:

• Diffusion capacity (corrected) at least 60%
• FEV_1 at least 65% of predicted

Other:

• HIV negative
• No history of seizures
• No mental disorders requiring medication (e.g., haloperidol)
• No active connective tissue disease
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or any carcinoma in situ
• No allergy to gentamicin
• No hypersensitivity to E. coli-derived preparations
• No history of severe allergy to sargramostim (GM-CSF) or filgrastim (G-CSF)
• No systemic infection
• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent corticosteroid therapy

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No contrast dye for 3 weeks after completion of interleukin-2 therapy

• Maximum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Leona A. Holmberg, MD, PhD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

FHCRC-1595.00

Identifier Type: -

Identifier Source: secondary_id

IMMUNEX-FHCRC-1595.00

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2037

Identifier Type: -

Identifier Source: secondary_id

CDR0000069095

Identifier Type: REGISTRY

Identifier Source: secondary_id

1595.00

Identifier Type: -

Identifier Source: org_study_id