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

Fred Hutchinson Cancer Center (FHCC)

Status and phase

Completed

Phase 2

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Lymphoma

Unspecified Childhood Solid Tumor, Protocol Specific

Treatments

Biological: aldesleukin

Drug: paclitaxel

Drug: thiotepa

Biological: sargramostim

Biological: filgrastim

Drug: melphalan

Drug: cyclophosphamide

Procedure: bone marrow ablation with stem cell support

Procedure: in vitro-treated peripheral blood stem cell transplantation

Drug: busulfan

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00027937

CDR0000069095 (Registry Identifier)

NCI-G01-2037

IMMUNEX-FHCRC-1595.00

FHCRC-1595.00

1595.00

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 56 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of solid tumor, Hodgkin's lymphoma, or B-cell non-Hodgkin's lymphoma
Eligible for autologous stem cell transplantation
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: