LymphomaPhase 2NCT00003416
S9805, High-Dose Melphalan Plus Peripheral Stem Cell Transplantation Followed by Interferon Alfa in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase 2 study testing filgrastim, recombinant interferon alfa and dexamethasone in people with Lymphoma, run by SWOG Cancer Research Network at 84 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, recombinant interferon alfa and dexamethasone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 84 sitesUnited States
- Study dates
- Sep 1998to Jan 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS: Immunologically diagnosed Waldenstrom's macroglobulinemia (WM) Evaluable quantifiable IgM One of the following criteria must be met: 1) Patient demonstrates clinical symptoms such as fatigue, dizziness, visual inacuity, or hemorrhagic manifestations of WM with anemia, hyperviscosity, thrombocytopenia, or coagulopathies 2) Advanced tumor mass present involving ONE of the following: Extensive lymphadenopathy (greater than 2 cm) Hepato or splenomegaly palpable on clinical examination Marked bone marrow infiltration greater than 50% 3) Progressive disease; i.e., increase in IgM concentration by at least 50%, and/or a drop of greater than 2 g/dL in hemoglobin (in the absence of gastrointestinal bleeding), and/or a greater than 50,000/mm3 decrease in platelets
PATIENT CHARACTERISTICS: Age: Under 70 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Cardiovascular: At least 6 months since myocardial infarction No congestive heart failure No arrhythmia refractory to therapy Ejection fraction within normal range by MUGA or ECHO Pulmonary: FEV1 at least 50% of predicted DLCO at least 50% of predicted Other: Not pregnant or nursing Effective contraception required of fertile patients No significant comorbid condition No uncontrolled life-threatening infection No uncontrolled diabetes No other malignancy within past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or adequately treated stage I or II cancer currently in remission HIV negative Hepatitis B surface antigen negative
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified
Trial locations and contacts
84 sites in 1 country.
84 sites in 1 country
United States84 sites
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, 87108-5138
University of New Mexico Cancer Research & Treatment Center
Albuquerque, New Mexico, 87131
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, 48105
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Veterans Affairs Medical Center - Biloxi
Biloxi, Mississippi, 39531-2410
Boston Medical Center
Boston, Massachusetts, 02118
Veterans Affairs Medical Center - Brooklyn
Brooklyn, New York, 11209
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45219
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, 45220-2288
Cleveland Clinic Cancer Center
Cleveland, Ohio, 44195
CCOP - Columbus
Columbus, Ohio, 43206
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, 45428
Veterans Affairs Medical Center - Denver
Denver, Colorado, 80220
University of Colorado Cancer Center
Denver, Colorado, 80262
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Henry Ford Hospital
Detroit, Michigan, 48202
Beckman Research Institute, City of Hope
Duarte, California, 91010
Dwight David Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905-5650
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
University of Texas Medical Branch
Galveston, Texas, 77555-1329
CCOP - Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
CCOP - Greenville
Greenville, South Carolina, 29615
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, 39216
Veterans Affairs Medical Center - Boston (Jamaica Plain)
Jamaica Plain, Massachusetts, 02130
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
Veterans Affairs Medical Center - Kansas City
Kansas City, Missouri, 64128
CCOP - Kansas City
Kansas City, Missouri, 64131
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576
CCOP - Dayton
Kettering, Ohio, 45429
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, 40511-1093
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, 72205
Veterans Affairs Medical Center - Long Beach
Long Beach, California, 90822
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
Texas Tech University Health Science Center
Lubbock, Texas, 79423
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, 94553
Loyola University Medical Center
Maywood, Illinois, 60153
MBCCOP - University of South Alabama
Mobile, Alabama, 36688
MBCCOP - LSU Medical Center
New Orleans, Louisiana, 70112
Tulane University School of Medicine
New Orleans, Louisiana, 70112
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, 70112
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
Veterans Affairs Medical Center - Oklahoma City
Oklahoma City, Oklahoma, 73104
CCOP - Greater Phoenix
Phoenix, Arizona, 85006-2726
Veterans Affairs Medical Center - Phoenix (Hayden)
Phoenix, Arizona, 85012
Oregon Cancer Center at Oregon Health Sciences University
Portland, Oregon, 97201-3098
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
CCOP - Columbia River Program
Portland, Oregon, 97213
University of California Davis Medical Center
Sacramento, California, 95817
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, 84148
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78284
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, 95403
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
Louisiana State University Hospital - Shreveport
Shreveport, Louisiana, 71130-3932
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, 71130
Providence Hospital - Southfield
Southfield, Michigan, 48075-9975
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
CCOP - Central Illinois
Springfield, Illinois, 62526
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65807
St. Louis University Health Sciences Center
St Louis, Missouri, 63110-0250
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, 63141
CCOP - Northwest
Tacoma, Washington, 98405-0986
Veterans Affairs Medical Center - Temple
Temple, Texas, 76504
CCOP - Scott and White Hospital
Temple, Texas, 76508
David Grant Medical Center
Travis Air Force Base, California, 94535
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, 85723
Arizona Cancer Center
Tucson, Arizona, 85724
CCOP - Wichita
Wichita, Kansas, 67214-3882
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
About this study
Official title: S9805, Phase II Study of Tandem High Dose Melphalan Supported by Peripheral Blood Stem Cell Support in Waldenstrom's Macroglobulinemia (WM)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. Interferon alfa may interfere with the growth of the cancer cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation followed by interferon alfa in treating patients with Waldenstrom's macroglobulinemia.
Read the detailed description
OBJECTIVES: I. Assess remission rates and overall and progression-free survival in patients with Waldenstrom's macroglobulinemia treated with tandem high dose melphalan supported by peripheral blood stem cell support. II. Assess the associated hematologic and nonhematologic toxicities of this regimen in these patients.
OUTLINE: Regimen A (dexamethasone induction): All patients receive high dose dexamethasone orally on days 1-4, 9-12, and 17-20; courses repeat every 35 days for a total of 3 courses. Regimen B (stem cell mobilization and collection): Following a 4-6 week break after dexamethasone induction and regardless of response or progression, patients have stem cells collected following administration of filgrastim (G-CSF) by injection; G-CSF continues until completion of stem cell collection (maximum of 6 aphereses). Regimen C (first peripheral blood stem cell transplant (PBSCT)): Regardless of disease progression, patients recovered from toxicities from dexamethasone induction and stem cell mobilization and collection, and who have adequate number of CD34 cells collected for at least 1 transplant, receive 1 dose of melphalan daily for 2 days followed by peripheral stem cell reinfusion. G-CSF is given by injection beginning on the day after peripheral stem cell reinfusion and continues until the absolute granulocyte count is greater than 1,000/mm3 on 3 consecutive days. Regimen D (second PBSCT): Patients who had adequate stem cell collection for 2 transplants during regimen B, have no evidence of disease progression after the first transplant, and have recovered from effects of previous treatment undergo a second treatment with high dose melphalan with PBSCT and G-CSF support, given 3-12 months following the first transplant. Patients who had enough cells collected for only one transplant go directly to regimen E. Regimen E (maintenance interferon alfa): Beginning 5-12 weeks after transplant and upon hematologic recovery of blood counts and other toxicities, patients with at least a partial response after high dose melphalan and PBSCT receive subcutaneous interferon alfa injections 3 times a week for 5 years or until disease progression, relapse, or toxicity. Patients are followed every month for 6 months, then every 3 months for 5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over 4 years.
- Conditions
- Lymphoma
- Being tested
- filgrastim, recombinant interferon alfa, dexamethasone, melphalan, peripheral blood stem cell transplantation
- Keywords
- Waldenström macroglobulinemia
- Medical subject headings
- Lymphoma, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
recombinant interferon alfaBiological
dexamethasoneDrug
melphalanDrug
peripheral blood stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Ind:
dexamethasone 40 mg/d PO D1-4,9-12,17-20 q35 days x 3 cycles
SC Collection:
cyclophosphamide 1.5gm/m2 IV q3 hrs x 2 mesna 3 gm/m2 conIV start with cyclo GCSF 5mcg/kg/d SQ start 1 day after cyclo until WBC > 50,000/mcg
Trans (x2):
melphalan 100 mg/m2/d IV D-1,-2 PBSC infusion D0
Maint:
interferon 3 million units/m2 SQ 3x/wk Receives: Biological: filgrastim; Biological: recombinant interferon alfa; Drug: dexamethasone; Drug: melphalan; Procedure: peripheral blood stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
confirmed remission rate
Measured: until death
overall survival (OS)
Measured: until death
progression free survival (PFS)
Measured: until death
toxicity
Measured: until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2004 (estimated)
- Study startSep 1998
- Primary completionAug 2000
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by SWOG Cancer Research NetworkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- SWOG Cancer Research Network
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Madhav Dhodapkar, MD, Study chair, Rockefeller University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003416
- Sponsor's protocol ID
- S9805
- Other IDs
- S9805, U10CA032102
- Status last verified
- Mar 2015
- First submitted
- 1 Nov 1999
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S9805, Phase II Study of Tandem High Dose Melphalan Supported by Peripheral Blood Stem Cell Support in Waldenstrom's Macroglobulinemia (WM)
- ClinicalTrials.gov ID
- NCT00003416
- Acronym / sponsor ID
- S9805
- Conditions
- Lymphoma
- Keywords
- Waldenström macroglobulinemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- SWOG Cancer Research NetworkResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 1998
- Primary completion
- Aug 2000 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 3 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. Interferon alfa may interfere with the growth of the cancer cells.
PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus peripheral stem cell transplantation followed by interferon alfa in treating patients with Waldenstrom's macroglobulinemia.
Detailed description
OBJECTIVES: I. Assess remission rates and overall and progression-free survival in patients with Waldenstrom's macroglobulinemia treated with tandem high dose melphalan supported by peripheral blood stem cell support. II. Assess the associated hematologic and nonhematologic toxicities of this regimen in these patients.
OUTLINE: Regimen A (dexamethasone induction): All patients receive high dose dexamethasone orally on days 1-4, 9-12, and 17-20; courses repeat every 35 days for a total of 3 courses. Regimen B (stem cell mobilization and collection): Following a 4-6 week break after dexamethasone induction and regardless of response or progression, patients have stem cells collected following administration of filgrastim (G-CSF) by injection; G-CSF continues until completion of stem cell collection (maximum of 6 aphereses). Regimen C (first peripheral blood stem cell transplant (PBSCT)): Regardless of disease progression, patients recovered from toxicities from dexamethasone induction and stem cell mobilization and collection, and who have adequate number of CD34 cells collected for at least 1 transplant, receive 1 dose of melphalan daily for 2 days followed by peripheral stem cell reinfusion. G-CSF is given by injection beginning on the day after peripheral stem cell reinfusion and continues until the absolute granulocyte count is greater than 1,000/mm3 on 3 consecutive days. Regimen D (second PBSCT): Patients who had adequate stem cell collection for 2 transplants during regimen B, have no evidence of disease progression after the first transplant, and have recovered from effects of previous treatment undergo a second treatment with high dose melphalan with PBSCT and G-CSF support, given 3-12 months following the first transplant. Patients who had enough cells collected for only one transplant go directly to regimen E. Regimen E (maintenance interferon alfa): Beginning 5-12 weeks after transplant and upon hematologic recovery of blood counts and other toxicities, patients with at least a partial response after high dose melphalan and PBSCT receive subcutaneous interferon alfa injections 3 times a week for 5 years or until disease progression, relapse, or toxicity. Patients are followed every month for 6 months, then every 3 months for 5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study over 4 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Biological: filgrastim, Biological: recombinant interferon alfa, Drug: dexamethasone, Drug: melphalan, Procedure: peripheral blood stem cell transplantationInd: dexamethasone 40 mg/d PO D1-4,9-12,17-20 q35 days x 3 cycles SC Collection: cyclophosphamide 1.5gm/m2 IV q3 hrs x 2 mesna 3 gm/m2 conIV start with cyclo GCSF 5mcg/kg/d SQ start 1 day after cyclo until WBC > 50,000/mcg Trans (x2): melphalan 100 mg/m2/d IV D-1,-2 PBSC infusion D0 Maint: interferon 3 million units/m2 SQ 3x/wk |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| filgrastim | Biological | treatment |
| recombinant interferon alfa | Biological | treatment |
| dexamethasone | Drug | treatment |
| melphalan | Drug | treatment |
| peripheral blood stem cell transplantation | Procedure or surgery | treatment |
Primary outcome
confirmed remission rate
Time frame: until death
overall survival (OS)
Time frame: until death
progression free survival (PFS)
Time frame: until death
toxicity
Time frame: until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Madhav Dhodapkar, MD study chair
Rockefeller University
84 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing filgrastim, recombinant interferon alfa and dexamethasone in people with Lymphoma, run by SWOG Cancer Research Network at 84 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
confirmed remission rate (time frame: until death). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.