S0410 Tandem Stem Cell Transplantation in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00233987 |
|
Recruitment Status :
Completed
First Posted : October 6, 2005
Results First Posted : February 5, 2013
Last Update Posted : March 1, 2018
|
Sponsor:
Southwest Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: carmustine Drug: cyclophosphamide Drug: etoposide Drug: melphalan Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Radiation: radiation therapy | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 98 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II |
| Study Start Date : | October 2005 |
| Actual Primary Completion Date : | November 2014 |
| Actual Study Completion Date : | December 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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.
|
Drug: carmustine
150 mg/m^2 IV over 2 hours 4, 5, and 6 days before transplant.
Other Name: BCNU Drug: cyclophosphamide 100 mg/kg IV 2 days before transplant. Drug: etoposide 60 mg/kg IV over 4 hours 4 days before transplant. Drug: 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.
Other Name: Total body irradiation (TBI) |
Primary Outcome Measures :
- 2-year Progression-free Survival [ Time Frame: At day 60, then every 6 months for 2 years ]Measured from date of randomization to date of first observation of progressive disease, or death due to any cause
Secondary Outcome Measures :
- Response Rate [ Time Frame: At day 60, then every 6 months for 2 years ]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.
- Overall Survival [ Time Frame: At day 60, then every 6 months for 2 years, then annually for a total of 7 years ]Measured from date of registration to date of death due to any cause or last contact
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug [ Time Frame: 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 ]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.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 15 Years to 70 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00233987
Locations
Show 53 study locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
| Study Chair: | Eileen P. Smith, MD | City of Hope Comprehensive Cancer Center | |
| Study Chair: | Patrick J. Stiff, MD | Loyola University | |
| Study Chair: | Louis S. Constine, MD | James P. Wilmot Cancer Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Southwest Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00233987 |
| Other Study ID Numbers: |
CDR0000442392 U10CA032102 ( U.S. NIH Grant/Contract ) S0410 ( Other Identifier: SWOG ) |
| First Posted: | October 6, 2005 Key Record Dates |
| Results First Posted: | February 5, 2013 |
| Last Update Posted: | March 1, 2018 |
| Last Verified: | January 2018 |
Keywords provided by Southwest Oncology Group:
|
recurrent adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Melphalan Carmustine Etoposide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |