Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265889
• Other study ID #: CCF5386
• Secondary ID: P30CA043703CCF-5
• Status: Completed
• Phase: Phase 2
• First received: December 14, 2005
• Last updated: October 28, 2013
• Start date: February 2002
• Est. completion date: April 2010

Study information

• Verified date: October 2013
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.

Description:

OBJECTIVES:

Primary

• Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-dose therapy with autologous stem cell rescue).

• Determine the response rate in patients treated with this regimen.

• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk [primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).

• Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.

• Autologous hematopoietic stem cell collection: Patients undergo autologous hematopoietic stem cell collection. Patients with an inadequate number of collected stem cells are removed from the study.

• First preparative regimen: Patients receive high-dose melphalan IV continuously over 16 hours on day -1.

• First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients proceed to second preparative regimen.

• Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over 2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second autologous SCT (day 0).

• Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically* confirmed Hodgkin's lymphoma meeting = 1 of the following criteria:

• Disease progression during initial first line chemotherapy

• Complete response lasting = 90 days after induction

• Partial response lasting = 90 days after induction

• First recurrence/progression with the duration of initial response = 12 months after completion of chemotherapy NOTE: *There must be unequivocal radiological evidence of recurrent or progressive disease if biopsy was not obtained at time of disease recurrence/progression

• No clonal abnormalities in marrow collection

• Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection

• Must have adequate sections of original diagnostic specimen available for review

• Needle aspirations or cytologies are not adequate

• No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free = 5 years)

• No CNS involvement

PATIENT CHARACTERISTICS:

Performance status

• Karnofsky 50-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin = 1.5 times upper limit of normal* (ULN) NOTE: *Unless due to Hodgkin's lymphoma

Renal

• Creatinine clearance = 60 mL/min

• Creatinine = 2.0 times ULN

Cardiovascular

• Ejection fraction = 45% by 2-D echocardiogram

• No significant active cardiac disease

Pulmonary

• Adequate pulmonary function

• DLCO = 45%

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer

• No known HIV or AIDS infection

• No active bacterial, fungal, or viral infection

• No medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Biological:
• filgrastim
480 mcg beginning day +5

Drug:
• busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
• cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
• etoposide
60 mg/kg, IV
• melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.

Procedure:
• autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation

Radiation:
• radiation therapy
radiation therapy

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.	one year after second transplant	No
Primary	Response Rate	Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.	One year after second transplant	No
Primary	Number of Patients That Experience Pulmonary Toxicity	Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.	One year after second transplant	Yes