S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

NCT ID: NCT00233987

Last Updated: 2018-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2017-12-31

Brief Summary

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.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

High-dose therapy plus tandem transplant

Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million cluster of differentiation 34 positive (CD34+) cells. Cycle 2 consists of either TBI-based or 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU)-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.

Group Type: EXPERIMENTAL

carmustine

Intervention Type: DRUG

150 mg/m\^2 IV over 2 hours 4, 5, and 6 days before transplant.

cyclophosphamide

Intervention Type: DRUG

100 mg/kg IV 2 days before transplant.

etoposide

Intervention Type: DRUG

60 mg/kg IV over 4 hours 4 days before transplant.

melphalan

Intervention Type: DRUG

150 mg/m\^2 IV 1 day before transplant.

autologous-autologous tandem hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

2.0 x 10\^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.

radiation therapy

Intervention Type: RADIATION

150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.

Interventions

carmustine

150 mg/m\^2 IV over 2 hours 4, 5, and 6 days before transplant.

Intervention Type: DRUG

cyclophosphamide

100 mg/kg IV 2 days before transplant.

Intervention Type: DRUG

etoposide

60 mg/kg IV over 4 hours 4 days before transplant.

Intervention Type: DRUG

melphalan

150 mg/m\^2 IV 1 day before transplant.

Intervention Type: DRUG

autologous-autologous tandem hematopoietic stem cell transplantation

2.0 x 10\^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.

Intervention Type: PROCEDURE

radiation therapy

150 centigray (cGy) total body irradiation given b.i.d on days 5-8 before transplant.

Intervention Type: RADIATION

Other Intervention Names

BCNU; Total body irradiation (TBI)

Eligibility Criteria

Inclusion 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 central nervous system (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 Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram

Pulmonary

• Adequate pulmonary function
• Corrected diffusing capacity of lung for carbon monoxide (DLCO) ≥ 60% OR
• Forced Expiratory Volume in One Side (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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eileen P. Smith, MD

Role: STUDY_CHAIR

City of Hope Comprehensive Cancer Center

Patrick J. Stiff, MD

Role: STUDY_CHAIR

Loyola University

Louis S. Constine, MD

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

University of California Davis Cancer Center

Sacramento, California, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Southwest Medical Center

Liberal, Kansas, United States

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, United States

Associates in Womens Health, PA - North Review

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, United States

CCOP - Wichita

Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, United States

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, United States

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, United States

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Providence Milwaukie Hospital

Milwaukie, Oregon, United States

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland, Oregon, United States

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, United States

Adventist Medical Center

Portland, Oregon, United States

CCOP - Columbia River Oncology Program

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland, Oregon, United States

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Auburn Regional Center for Cancer Care

Auburn, Washington, United States

St. Joseph Cancer Center

Bellingham, Washington, United States

Olympic Hematology and Oncology

Bremerton, Washington, United States

Providence Centralia Hospital

Centralia, Washington, United States

St. Francis Hospital

Federal Way, Washington, United States

Columbia Basin Hematology

Kennewick, Washington, United States

Providence St. Peter Hospital Regional Cancer Center

Olympia, Washington, United States

Good Samaritan Cancer Center

Puyallup, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Harborview Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Group Health Central Hospital

Seattle, Washington, United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, United States

Polyclinic First Hill

Seattle, Washington, United States

University Cancer Center at University of Washington Medical Center

Seattle, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Franciscan Cancer Center at St. Joseph Medical Center

Tacoma, Washington, United States

Allenmore Hospital

Tacoma, Washington, United States

CCOP - Northwest

Tacoma, Washington, United States

MultiCare Regional Cancer Center at Tacoma General Hospital

Tacoma, Washington, United States

St. Clare Hospital

Tacoma, Washington, United States

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, United States

Countries

United States

References

Smith EP, Li H, Friedberg JW, Constine LS, Rimsza LM, Cook JR, Laport GG, Popplewell LL, Holmberg LA, Smith SM, LeBlanc M, Forman SJ, Fisher RI, Stiff PJ. Tandem Autologous Hematopoietic Cell Transplantation for Patients with Primary Progressive or Recurrent Hodgkin Lymphoma: A SWOG and Blood and Marrow Transplant Clinical Trials Network Phase II Trial (SWOG S0410/BMT CTN 0703). Biol Blood Marrow Transplant. 2018 Apr;24(4):700-707. doi: 10.1016/j.bbmt.2017.12.798. Epub 2017 Dec 28.

Reference Type: DERIVED

PMID: 29289757 (View on PubMed)

Other Identifiers

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S0410

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000442392

Identifier Type: -

Identifier Source: org_study_id