Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00233987

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill cancer cells. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy with a peripheral stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Tandem (two) autologous stem cell transplants may be an effective treatment for Hodgkin's lymphoma.

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

Condition	Intervention	Phase
Lymphoma	Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: melphalan Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Cyclophosphamide Etoposide Carmustine Melphalan Etoposide phosphate Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

3-year progression-free survival [ Designated as safety issue: No ]

Estimated Enrollment:	85
Study Start Date:	October 2005
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the 2-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 multicenter study.

Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy. No more than 6 weeks later, patients proceed to autologous hematopoietic stem cell collection.
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.
Pre-transplant salvage radiation: Patients with residual tumor greater than 5 cm after initial salvage therapy undergo involved-field radiotherapy. All patients then proceed to the first preparative regimen.
First preparative regimen: Patients receive high-dose melphalan IV on day -1.
First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. At least 28 days later, patients proceed to second preparative regimen.
Second preparative regimen: Patients receive 1 of the following preparative regimens:
- Total-body irradiation (TBI)-based regimen: Patients undergo TBI twice daily on days -8 to -5. Patients also receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 1 hour on day -2.
- Carmustine-based regimen: Patients receive carmustine IV over 2 hours on days -6 to -4, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2.
Second autologous SCT: Patients undergo second autologous SCT on day 0. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 7 years.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study over 2 years.

Eligibility

Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed Hodgkin's lymphoma
- Relapsed or refractory disease
- Biopsy or radiological evidence of disease at time of recurrence/progression required
Has received ≥ 1 prior systemic chemotherapy regimen
No clonal abnormalities in marrow collection
Must undergo involved-field radiotherapy if bulky disease > 5 cm
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)
Patients who relapse after achieving a complete remission must complete a minimum of 2 courses of salvage chemotherapy or radiation therapy to determine if sensitive or resistant recurrent disease is present
No CNS involvement

PATIENT CHARACTERISTICS:

Age

15 to 70

Performance status

Zubrod 0-2

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

Bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Hodgkin's disease)

Renal

Creatinine clearance ≥ 60 mL/min
Creatinine ≤ 2 times upper limit of normal

Cardiovascular

None of the following conditions requiring therapy:
- Coronary artery disease
- Cardiomyopathy
- Congestive heart failure
- Arrhythmias
Ejection fraction ≥ 45% by MUGA or 2-D echocardiogram

Pulmonary

Adequate pulmonary function
Corrected DLCO ≥ 60% OR
FEV_1≥ 60% of predicted

Other

Not pregnant or nursing
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:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233987

Show 53 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Eileen P. Smith, MD	Beckman Research Institute
Investigator:	Patrick J. Stiff, MD	Loyola University
Investigator:	Louis S. Constine, MD	James P. Wilmot Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000442392, SWOG-S0410
Study First Received:	October 5, 2005
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00233987
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:

Melphalan
Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Carmustine
Cyclophosphamide
Etoposide phosphate

Recurrence
Lymphatic Diseases
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Etoposide

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents

Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009