Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A
N/A
N/A
Both
Hodgkin Disease
Trial Information
Immune Reconstitution and Biomarker Identification in Patients With Newly Diagnosed Low and Intermediate Risk Hodgkins Lymphoma Receiving Chemotherapy With or Without Radiation Therapy: TXCH-HD-12A
At first the subject will have 2 cycles of cancer drugs (Doxorubicin, Bleomycin,
Vincristine, Etoposide, Cyclophosphamide). The doctors call this combination of cancer drugs
ABVE-PC for short. A cycle equals 21 days. The cancer drugs will be given intravenously
(IV).
Those patients evaluated as having an early response to treatment will be put in the group
of Rapid Early Responders (RERs). The RER group includes those patients whose disease has
been reduced by 60% or more. The next step for patients with RERs is 2 more cycles of
ABVE-PC chemotherapy followed by another evaluation of their response. Those determined to
have a complete response (at least an 80% disease reduction) will receive no further
therapy. Those patients determined to have less than a complete response will receive
radiation therapy within 6 weeks after the last cycle or when blood counts are recovered.
Radiation therapy will be given to the involved areas and by the standard of care of this
hospital (Texas Children's Hospital). After radiation the subject will be off treatment.
Patients with disease reduction less than 60% are put in the group of Slow Early Responders
(SERs). The next step for patients with SER is 2 cycles of DECA (Dexamethasone, Etoposide,
Cytarabine, and Cisplatin). On Days 1 and 2, the subject will be given dexamethasone IV
first; afterwards, then they will receive the Etoposide and Cytarabine mixture. Cisplatin
will be given by IV only on Day 1.
BIOLOGY TESTS The doctors are investigating molecules in tumors and blood that may help them
better understand the biology of Hodgkin's Disease. These studies may also help them
understand differences in patients' responses to therapy.
TISSUE FOR BIOMARKER STUDIES The doctors want to study the material that shows the make-up
of the cancer (the genes of the cancer tissue) and the special "markers" of the tissue.
Tissue from the subject's cancer biopsies will be used for these studies. They will collect
these samples when the subject has a biopsy for clinical reasons.
IMMUNE FUNCTION AND BIOMARKER BLOOD TESTS The doctors also want to collect blood samples to
study the subject's immune system and to look at biomarkers in the blood.
Inclusion Criteria:
Patients with newly diagnosed, histologically confirmed Hodgkin Lymphoma (HD) who meet the
following criteria:
- Stage IA and IB
- Stage IIA and IIB
- Stage IIIA
- Stage IVA
Exclusion Criteria:
- Patients with lymphocyte predominant histology
- Patients who have received previous chemotherapy or radiation therapy (does NOT
include steroids).
- Patients with symptomatic cardiac failure unrelieved by medical therapy or evidence
of significant cardiac dysfunction by echocardiogram (shortening fraction <27%).
- Patients with severe renal disease (i.e. Measured or estimated creatinine clearance
or radioisotope GFR <= 70 ml/min/1.73 m2).
- Patients with pre-existing severe restrictive pulmonary disease (FVC less than 60% of
predicted).
- Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or AST
greater than 500 IU/L).
- Known HIV positivity
- Patients with a Karnofsky performance score <70% or Lansky score <70%.
- Female patients who are pregnant or breast feeding.
- Patients with baseline hearing as measured by audiometry below 95% for age and
gender.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response to therapy from Day 1 of Treatment
Outcome Description:
To define the general immune recovery in patients with low and intermediate risk HD undergoing chemotherapy with or without radiation therapy. Descriptive analysis of response to therapy, event-free survival, overall survival, relapse, and infection will be summarized using summary statistics.
Outcome Time Frame:
up to 18 months
Safety Issue:
Yes
Principal Investigator
Carl E. Allen, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Baylor College of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
H-30993 TXCH-HD-12A
NCT ID:
NCT01858922
Start Date:
December 2012
Completion Date:
June 2017
Related Keywords:
- Hodgkin Disease
- Hodgkin's Lymphoma
- ABVE-PC
- doxorubicin
- bleomycin
- vincristine
- etoposide
- prednisone
- cyclophosphamide
- DECA
- decadron
- cisplatin
- cytarabine
- Radiation
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Texas Children's Hospital | Houston, Texas |
