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

Lymphoma Clinical Trial

Official title:

A Phase II Study Of Mobilization Chemotherapy With GMCSF And GCSF Followed By High Dose Therapy Combined With IL2 Activated Autologous Peripheral Blood Stem Cells Followed By Sequential IL2 Therapy As Treatment For Solid Tumors And Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00027937
• Other study ID #: 1595.00
• Secondary ID: FHCRC-1595.00IMM
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2001
• Last updated: May 12, 2010
• Start date: August 2001
• Est. completion date: November 2007

Study information

• Verified date: May 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 56 Years

Eligibility

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:

• 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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific
• Unspecified Childhood Solid Tumor, Protocol Specific

Intervention

Biological:
• aldesleukin

• filgrastim

• sargramostim

Drug:
• busulfan

• cyclophosphamide

• melphalan

• paclitaxel

• thiotepa

Procedure:
• bone marrow ablation with stem cell support

• in vitro-treated peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,