Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Older Patients With Refractory or Relapsed Intermediate-Grade Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

A Phase II Trial of ICE Chemotherapy Followed by High Dose BEAM Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients >= 60 Years Old With Refractory or Relapsed Intermediate Grade Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002982
• Other study ID #: 97-004
• Secondary ID: CDR0000065505NCI
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 1, 2013
• Start date: January 1997
• Est. completion date: October 2005

Study information

• Verified date: July 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with peripheral stem cell transplantation works in treating older patients with refractory or relapsed intermediate-grade non-Hodgkin's lymphoma.

Description:

OBJECTIVES:

• Assess the efficacy and toxic effects of carmustine/etoposide/melphalan (ICE) chemotherapy followed by peripheral blood progenitor cell transplantation in patients with refractory or relapsed intermediate grade non-Hodgkin's lymphoma.

• Assess the ability of the ICE chemotherapy regimen, in conjunction with filgrastim, to mobilize peripheral blood stem cells.

OUTLINE: This is a descriptive pilot study.

Patients receive 3 cycles of induction chemotherapy with ifosfamide, carboplatin, and etoposide (ICE). Each cycle is given at least 14 days apart. Patients receive etoposide IV on days 1 through 3. Carboplatin and ifosfamide with mercaptoethane sulfonate is given IV over 24 hours on day 2.

During cycles 1 and 2, patients receive filgrastim (G-CSF) SC every 6 hours beginning on day 1 and continuing until the desired absolute neutrophil count (ANC) is attained.

Patients receive at least 24 hours of rest before PBPC infusion on day 0.

Following cycle 3, G-CSF is given SC beginning on day 6 and continuing until completion of PBPC collection. However, bone marrow will be harvested if an insufficient number of stem cells are collected after 5 leukaphereses.

Patients with residual disease limited to 2 sites receive radiation therapy twice a day within 2 weeks prior to high dose BEAM chemotherapy with carmustine, etoposide, cytarabine, and melphalan.

Patients receive carmustine IV on day -7. Etoposide and cytarabine are given IV every 12 hours on days -6 through -3. Melphalan is given IV on day -2.

G-CSF is administered every 12 hours beginning on day 1 and continuing until the desired ANC is attained. If ANC is attenuated on day 21, patients undergo a repeat bone marrow biopsy and receive filgrastim SC.

Patients are followed for 2 years posttransplant, then for 3 to 5 years at 4 month intervals and every 6 months following the fifth posttransplant.

PROJECTED ACCRUAL: This study will accrue 30 patients for the duration of 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Primary refractory intermediate grade non-Hodgkin's lymphoma (NHL) OR

• Untreated relapsed intermediate grade NHL with no more than 1 extranodal site of disease

• Biopsy proven relapse of diffuse large cell, diffuse mixed cell, diffuse small cleaved cell (excluding mantle cell lymphoma), follicular large cell, anaplastic large cell or immunoblastic NHL in recently attained complete response patients

PATIENT CHARACTERISTICS:

Age:

• 60 and over

Performance status:

• Karnofsky at least 80%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.0 mg/dL unless there is a history of Gilbert's disease

Renal:

• No history of chronic renal insufficiency

• Creatinine no greater than 1.5 mg/dL or if greater than 1.5 mg/dL, then creatinine clearance must be at least 60 mL/min

Cardiovascular:

• No myocardial infarction within the past 6 months

• No unstable angina or cardiac arrhythmias other than chronic atrial fibrillation

• Normal cardiac function required; MUGA scan or stress ECG ejection fraction at least 50% without significant wall motion abnormalities

Pulmonary:

• Adequate pulmonary function defined as DLCO at least 50% of predicted value when corrected for patients hemoglobin and alveolar ventilation

Other:

• No medical illness unrelated to intermediate grade Non-Hodgkin's Lymphoma

• No uncontrolled infection

• No history of malignancy other than curatively treated cutaneous basal cell carcinoma; carcinoma in situ of the cervix; axillary node negative breast cancer without prior chemotherapy and disease free for more than 2 years; or prostate cancer with surgery alone and disease free for more than 2 years

• No lymphoblastic lymphoma, small noncleaved cell lymphoma, CNS lymphoma or CNS relapse of lymphoma

• Not HIV, HBV, and HCV positive

PRIOR CONCURRENT THERAPY:

• Concurrent enrollment in MSKCC protocol 96-17a allowed

Biologic therapy:

• Not specified

Chemotherapy:

• No more than 2 prior chemotherapy regimens

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• filgrastim

Drug:
• carboplatin

• carmustine

• cytarabine

• etoposide

• ifosfamide

• melphalan

Procedure:
• autologous bone marrow transplantation

• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-related toxicity			Yes
Secondary	Efficacy in terms of 2-year disease-free survival			No