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Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II


Phase 2
15 Years
70 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Recurrent Hodgkin's Disease (A BMT Study), Phase II


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

2-year Progression-free Survival

Outcome Description:

Measured from date of randomization to date of first observation of progressive disease, or death due to any cause

Outcome Time Frame:

At day 60, then every 6 months for 2 years

Safety Issue:

No

Principal Investigator

Eileen P. Smith, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Federal Government

Study ID:

CDR0000442392

NCT ID:

NCT00233987

Start Date:

October 2005

Completion Date:

February 2016

Related Keywords:

  • Lymphoma
  • recurrent adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - NorthwestTacoma, Washington  98405-0986
University of California Davis Cancer CenterSacramento, California  95817
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Southwest Medical CenterLiberal, Kansas  67901
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Adventist Medical CenterPortland, Oregon  97216
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
St. Joseph Cancer CenterBellingham, Washington  98225
Providence Centralia HospitalCentralia, Washington  98531-9027
Columbia Basin HematologyKennewick, Washington  99336
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Auburn Regional Center for Cancer CareAuburn, Washington  98002