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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00070187




Registration number
NCT00070187
Ethics application status
Date submitted
3/10/2003
Date registered
7/10/2003
Date last updated
17/10/2013

Titles & IDs
Public title
Immunotherapy Using Cyclosporine, Interferon Gamma, and Interleukin-2 After High-Dose Myeloablative Chemotherapy With Autologous Stem Cell Transplantation in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma
Scientific title
A Phase II/III Study of Immunomodulation After High Dose Myeloablative Therapy With Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin Disease
Secondary ID [1] 0 0
CDR0000330135
Secondary ID [2] 0 0
AHOD0121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - aldesleukin
Other interventions - filgrastim
Other interventions - recombinant interferon gamma
Treatment: Drugs - carmustine
Treatment: Drugs - cyclosporine
Treatment: Drugs - cytarabine
Treatment: Drugs - etoposide
Treatment: Drugs - melphalan
Treatment: Surgery - autologous bone marrow transplantation
Treatment: Surgery - bone marrow ablation with stem cell support
Treatment: Surgery - peripheral blood stem cell transplantation

Experimental: Hyperfractionated Involved-Field Radiotion-immunotherapy - Completed prior salvage induction therapy and have not received full tissue tolerance from prior radiotherapy may receive hyperfractionated involved-field radiotherapy twice daily for 7 days.
HIGH-DOSE PREPARATIVE REGIMEN: Beginning within 7 days after radiotherapy, carmustine IV over 3 hours on day -6; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV over 30 minutes on day -1.
ASCT: Autologous bone marrow or peripheral blood stem cell transplantation on day 0. Filgrastim (oral or IV) beginning on day 1 and continuing until blood counts recover.
IMMUNOTHERAPY: Cyclosporine IV twice daily beginning on day 0 and continuing until the completion of the course of recombinant interferon gamma and interleukin-2. When sufficiently recovered, Aldesleukin once daily for 18 days.

Experimental: Hyperfractionated Involved-Field Radiotion-no immunotherapy - Completed prior salvage induction therapy and have not received full tissue tolerance from prior radiotherapy may receive hyperfractionated involved-field radiotherapy twice daily for 7 days.
HIGH-DOSE PREPARATIVE REGIMEN: Beginning within 7 days after radiotherapy, carmustine IV over 3 hours on day -6; etoposide IV over 1 hour and cytarabine IV over 1 hour on days -5 to -2; and melphalan IV over 30 minutes on day -1.
ASCT: Autologous bone marrow or peripheral blood stem cell transplantation on day 0. Filgrastim (oral or IV) beginning on day 1 and continuing until blood counts recover.


Other interventions: aldesleukin
Given IV

Other interventions: filgrastim
Given IV

Other interventions: recombinant interferon gamma
Given IV

Treatment: Drugs: carmustine
Given IV

Treatment: Drugs: cyclosporine
Given IV

Treatment: Drugs: cytarabine
Given IV

Treatment: Drugs: etoposide
Given IV

Treatment: Drugs: melphalan
Given IV

Treatment: Surgery: autologous bone marrow transplantation


Treatment: Surgery: bone marrow ablation with stem cell support


Treatment: Surgery: peripheral blood stem cell transplantation
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of death, excluding death due to disease, during the period of time from day 0 (transplant) through day 100 post transplant
Timepoint [1] 0 0
Day 0 (transplant) through Day 100 (Post transplant)

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of Hodgkin's lymphoma

- Histologically confirmed at original diagnosis AND at relapse or disease
progression

- Relapsed or refractory to conventional therapy

- No recurrence without B symptoms or bulky disease at least 1 year after completion of
minimal systemic therapy defined by either of the following:

- Stage IA/IIA with nodal disease previously treated with radiotherapy only

- Stage IA/IIA with nodal disease previously treated with less than 3 courses of
standard dose chemotherapy

- Concurrently enrolled on the COG-AHOD00P1 salvage chemotherapy study OR received other
appropriate salvage therapy (e.g., ifosfamide and vinorelbine)

PATIENT CHARACTERISTICS:

Age

- Under 30

Performance status

- ECOG 0-2 (for adults)

- Lansky 50-100% (for children)

Life expectancy

- At least 2 months

Hematopoietic

- Absolute neutrophil count at least 500/mm^3

Hepatic

- Bilirubin no greater than 1.5 times normal

- SGPT less than 2.5 times normal

Renal

- Creatinine no greater than 1.5 times normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70
mL/min/1.73 m^2

Cardiovascular

- Shortening fraction at least 27% by echocardiogram OR

- Ejection fraction at least 50% by MUGA

Pulmonary

- No evidence of dyspnea at rest

- No exercise intolerance

- DLCO at least 50% (patients 8 years of age and over)

Other

- Not pregnant or nursing

- Negative pregnancy test

- No concurrent serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Recovered from prior immunotherapy

- At least 1 week since prior antineoplastic biologic agents

- More than 1 week since prior growth factors

- No prior stem cell transplantation

- No other concurrent immunomodulating agents

Chemotherapy

- See Disease Characteristics

- More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas)
and recovered

- No other concurrent anticancer chemotherapy

Endocrine therapy

- No concurrent steroids, including dexamethasone as an antiemetic

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery

- Not specified

Other

- No concurrent participation in another COG therapeutic study
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Delaware
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Canada
State/province [30] 0 0
Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation
may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell
transplantation may help the transplanted cells make an immune response and kill any
remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by
autologous stem cell transplantation is more effective with or without immunotherapy.

PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy
followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and
interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem
cell transplantation only in treating patients with refractory or relapsed Hodgkin's
lymphoma.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00070187
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Allen R. Chen, MD, PhD, MHS
Address 0 0
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00070187