Phase 2 N=118 Treatment

Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma

Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00003631 ↗

Enrolled (actual)

118

Serious AEs

11.0%

Results posted

Jan 2016

Primary outcome: Primary: Objective Response — 3; 6; 3; 2 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); carboplatin (Drug); carmustine (Drug); cyclophosphamide (Drug); cytarabine (Drug); etoposide (Drug); ifosfamide (Drug); melphalan (Drug); bone marrow ablation with stem cell support (Procedure); peripheral blood stem cell transplantation (Procedure); radiation therapy (Radiation)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response	3; 6; 3; 2; 1; 0	—

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with refractory or relapsed Hodgkin's lymphoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed residual or relapsed Hodgkin's lymphoma following conventional dose standard chemotherapy
Presence of the following prognostic factors are allowed:
B symptoms (fever, weight loss, night sweats)
Extranodal disease
Complete remission of less than 1 year duration

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease
No chronic active or persistent hepatitis

Renal:

No history of chronic renal insufficiency
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

No myocardial infarction within the past 6 months
No unstable angina
No significant cardiac arrhythmias other than chronic atrial fibrillation
Ejection fraction at least 50%

Pulmonary:

DLCO at least 50%

Other:

No uncontrolled infection
HIV negative
At least 5 years since prior malignancy except:
Curatively treated cutaneous basal cell carcinoma
Carcinoma in situ of the cervix
Not pregnant or nursing
Fertile women must use effective contraception

PRIOR CONCURRENT THERAPY:

Must have failed conventional dose standard chemotherapy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00003631). 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.