Lymphoma
Conditions
Keywords
Lymphoma, Hodgkin's Disease, Stage III and IV, Adriamycin, Doxorubicin, Rubex, Bleomycin, Bleomycin Sulfate, BLM, Dacarbazine, DTIC-DOME, Interferon-2A, Interferon-Alfa-2a, Roferon-A, Velban, Vinblastine
Brief summary
This is a clinical research study of interferon (IFN) plus chemotherapy with the standard combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD improves the immune response against Hodgkin's disease, and will determine whether the toxicity of ABVD is increased by adding IFN.
Detailed description
Each treatment cycle will last 2 weeks. On days 1 - 4 of each cycle, patients will be given a shot of IFN under the skin. On day 4, patients will be given ABVD through a vein over one-hour. The plan is for patients to receive 12 cycles of treatment. However, patients will leave the study if they have severe side effects or if the cancer grows or spreads. They will also leave if the cancer does not improve after 6 cycles. Patient who leave the study will be offered other treatments. A maximum of 35 patients will be treated with that dose. Before the first treatment, patient will have a physical exam, blood tests, and a heart scan. Within 1 month of starting treatment, patients will have a chest X-ray, CT scans of the abdomen and pelvis, and a gallium scan. During the study, patient will have blood tests every week and a physical exam every 2 weeks. The X-ray, CT scans, and gallium scan will be repeated after cycles 6 and 12. All the drugs in this study are approved by the U.S. Food and Drug Administration and are available by prescription. ABVD is a standard treatment for Hodgkin's disease; IFN is an investigational treatment for Hodgkin's disease. About 35 patients will be enrolled in the study. All treatment will be given in the outpatient clinic at M.D. Anderson Cancer Center.
Interventions
DRUGInterferon-2A
4 (x106 IU/m\^2) subcutaneously on days 1-4.
DRUGAdriamycin
25 mg/m\^2 by vein on day 4.
DRUGBleomycin
10 mg/m\^2 by vein on day 4.
DRUGVelban
6 mg/m\^2 by vein on day 4.
DRUGDacarbazine
375 mg/m\^2 by vein on day 4.
Sponsors
Schering-Plough
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Hodgkin's disease patients who relapse after radiation therapy alone, or in combination with Novantrone, Oncovin, Velban, and Prednisone (NOVP); and previously untreated patients with stage III and IV who are eligible for standard ABVD therapy. 2. Must have adequate bone marrow reserve Absolute neutrophil count (ANC) \> 1,000/uL, Platelets \> 100,000 3. Left ventricular ejection fraction (LVEF) \>/= 50%, serum creatinine \< 2mg/dl, serum bilirubin \< 2mg/dl
Exclusion criteria
1. No prior therapy with Mustargen Oncovin Procarbazine Prednisone (MOPP). 2. No severe pulmonary disease including Chronic obstructive pulmonary disease (COPD) and asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants' Response | After 6 courses (3 months) | Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: \> 25 % increase in size of any measurable lesion or appearance of significant new lesions. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: July 25, 1996 through March 3, 2000. All participants were recruited at UT MD Anderson Cancer Center.
Pre-assignment details
Of the 35 participants registered, five (5) were excluded from the trial.
Participants by arm
| Arm | Count |
|---|---|
| Interferon-2A + Chemotherapy Interferon-2A 4 (x106 IU/m\^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m\^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV) | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Interferon-2A + Chemotherapy |
|---|---|
| Age Continuous | 30 years |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 3 / 30 |
Outcome results
Primary
Participants' Response
Complete Response (CR): Disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial Response (PR): 50% or greater decrease in sum of products all measured lesions persisting for at least 4 weeks. No Change: Steady state or change of +/- 25% of tumor size and no progression for minimum of 8 weeks with no appearance of new lesions. Progressive Disease: \> 25 % increase in size of any measurable lesion or appearance of significant new lesions.
Time frame: After 6 courses (3 months)
Population: Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Interferon-2A + Chemotherapy | Participants' Response | Complete Response | 23 participants |
| Interferon-2A + Chemotherapy | Participants' Response | Uncomfirmed Complete Response | 2 participants |
| Interferon-2A + Chemotherapy | Participants' Response | Partial Response | 3 participants |
| Interferon-2A + Chemotherapy | Participants' Response | Progressive Disease | 1 participants |