Phase 2 N=98 Treatment

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

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00233987 ↗

Enrolled (actual)

Serious AEs

2.2%

Results posted

Feb 2013

Primary outcome: Primary: 2-year Progression-free Survival — 59 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: carmustine (Drug); cyclophosphamide (Drug); etoposide (Drug); melphalan (Drug); autologous-autologous tandem hematopoietic stem cell transplantation (Procedure); radiation therapy (Radiation)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: SWOG Cancer Research Network
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 2-year Progression-free Survival	59	—
SECONDARY Response Rate	15; 8; 3; 2; 33; 26	—
SECONDARY Overall Survival	91	—
SECONDARY Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	6; 4; 3; 20; 1; 1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00233987). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.