S0410 Tandem Stem Cell Transplantation 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 Recurrent Hodgkin's Disease (A BMT Study), Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233987
• Other study ID #: CDR0000442392
• Secondary ID: U10CA032102S0410
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: January 31, 2018
• Start date: October 2005
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Southwest Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2017
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• carmustine
150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.
• cyclophosphamide
100 mg/kg IV 2 days before transplant.
• etoposide
60 mg/kg IV over 4 hours 4 days before transplant.
• melphalan
150 mg/m^2 IV 1 day before transplant.

Procedure:
• autologous-autologous tandem hematopoietic stem cell transplantation
2.0 x 10^6 CD34+ cells, beginning at least 24 hours after melphalan infusion.

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

Locations

Country	Name	City	State
United States	Tulane Cancer Center Office of Clinical Research	Alexandria	Louisiana
United States	Auburn Regional Center for Cancer Care	Auburn	Washington
United States	St. Joseph Cancer Center	Bellingham	Washington
United States	Mountain States Tumor Institute at St. Luke's Regional Medical Center	Boise	Idaho
United States	Olympic Hematology and Oncology	Bremerton	Washington
United States	Providence Centralia Hospital	Centralia	Washington
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	St. Francis Hospital	Federal Way	Washington
United States	Legacy Mount Hood Medical Center	Gresham	Oregon
United States	Cancer Center of Kansas-Independence	Independence	Kansas
United States	Columbia Basin Hematology	Kennewick	Washington
United States	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas
United States	Thompson Cancer Survival Center	Knoxville	Tennessee
United States	Southwest Medical Center	Liberal	Kansas
United States	Cardinal Bernardin Cancer Center at Loyola University Medical Center	Maywood	Illinois
United States	Providence Milwaukie Hospital	Milwaukie	Oregon
United States	Cancer Center of Kansas, PA - Newton	Newton	Kansas
United States	Providence St. Peter Hospital Regional Cancer Center	Olympia	Washington
United States	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas
United States	Adventist Medical Center	Portland	Oregon
United States	CCOP - Columbia River Oncology Program	Portland	Oregon
United States	Legacy Emanuel Hospital and Health Center and Children's Hospital	Portland	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	Providence St. Vincent Medical Center	Portland	Oregon
United States	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas
United States	Good Samaritan Cancer Center	Puyallup	Washington
United States	University of California Davis Cancer Center	Sacramento	California
United States	Cancer Center of Kansas, PA - Salina	Salina	Kansas
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Group Health Central Hospital	Seattle	Washington
United States	Harborview Medical Center	Seattle	Washington
United States	Minor and James Medical, PLLC	Seattle	Washington
United States	Polyclinic First Hill	Seattle	Washington
United States	Swedish Cancer Institute at Swedish Medical Center - First Hill Campus	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	Allenmore Hospital	Tacoma	Washington
United States	CCOP - Northwest	Tacoma	Washington
United States	Franciscan Cancer Center at St. Joseph Medical Center	Tacoma	Washington
United States	MultiCare Regional Cancer Center at Tacoma General Hospital	Tacoma	Washington
United States	St. Clare Hospital	Tacoma	Washington
United States	Legacy Meridian Park Hospital	Tualatin	Oregon
United States	Southwest Washington Medical Center Cancer Center	Vancouver	Washington
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

Sponsors (2)

Lead Sponsor	Collaborator
Southwest Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year Progression-free Survival	Measured from date of randomization to date of first observation of progressive disease, or death due to any cause	At day 60, then every 6 months for 2 years
Secondary	Response Rate	Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.	At day 60, then every 6 months for 2 years
Secondary	Overall Survival	Measured from date of registration to date of death due to any cause or last contact	At day 60, then every 6 months for 2 years, then annually for a total of 7 years
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.	Assessed after cycle 1 high dose therapy, after cycle 2 high dose therapy, and at 1 month and 2 months after the second stem cell infusion