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Chemotherapy Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma

Intervention: bleomycin sulfate (Biological); ABVD regimen (Drug); BEACOPP regimen (Drug); cyclophosphamide (Drug); dacarbazine (Drug); doxorubicin hydrochloride (Drug); etoposide (Drug); prednisone (Drug); procarbazine hydrochloride (Drug); vinblastine (Drug); vincristine sulfate (Drug); laboratory biomarker analysis (Other); computed tomography (Procedure); fludeoxyglucose F 18 (Radiation); selective external radiation therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eastern Cooperative Oncology Group

Official(s) and/or principal investigator(s):
Ranjana Advani, MD, Principal Investigator, Affiliation: Stanford University

Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine, dacarbazine, cyclophosphamide, etoposide, procarbazine hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells. Comparing results of imaging procedures, such as PET scans and CT scans, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This phase II clinical trial studies how well chemotherapy based on PET/CT scan works in treating patients with stage I or stage II Hodgkin lymphoma.

Clinical Details

Official title: Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)

Study design: Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 36-month progression-free survival

Secondary outcome:

PET-positive rate

PET-negative rate

Complete response

Toxicity of response-adapted chemotherapy

Detailed description: OBJECTIVES: Primary

- To evaluate the progression-free survival (PFS) at 36 months following registration for

patients who are positron emission tomography (PET) negative after 2 courses of chemotherapy, and receive 4 additional courses of doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) followed by involved-nodal radiotherapy [INRT] of 30-30. 6 Gy. Secondary

- To evaluate the PET-negative rate after 2 courses of ABVD chemotherapy in patients with

stage I/II Hodgkin lymphoma with bulky mediastinal disease.

- To evaluate the PFS at 36 months for patients who are PET positive after 2 courses of

chemotherapy and receive 4 courses of escalated bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, vincristine sulfate, procarbazine hydrochloride, and prednisone (BEACOPP) followed by INRT of 30-30. 6 Gy.

- To evaluate the complete response (CR) rate and overall survival (OS) for PET-positive

and PET-negative patients after 2 courses of ABVD.

- To identify sites of relapse following combined-modality therapy (CMT) for patients

with large mediastinal adenopathy and correlate with RT fields.

- To assess toxicity on both arms of study.

- To assess reproductive function at baseline and at 3 years after ABVD or escalated

BEACOPP with specific serum markers.

- To bank serum and plasma at baseline and selected time points to assess the prognostic

value of various markers such as, but not limited to, SCD30, IL10, CCL17, CCL22, and MDC.

- To create tissue microarrays (TMAs) from patient tumor blocks for future biomarker

assessment including, but not limited to, bcl-2, FOXP3, and macrophage content.

- To measure serum TARC levels pre-treatment and post two courses of ABVD and correlate

with PET-CT findings (performed at same time points) and 3 year PFS. Tertiary

- To assess the predictive value of fludeoxyglucose F 18 (18FDG) uptake, as measured by

semi-quantitative measurements including standard uptake variables (SUVs), with respect to response at the end of chemotherapy and PFS.

- To compare the predictive value for response and PFS of FDG uptake alone to that of FDG

uptake in combination with CT size change information.

- To compare the predictive value for response and PFS of FDG uptake alone to that of FDG

uptake in combination with available serum and tissue molecular biomarkers.

- To compare the results of the secondary imaging objectives with the corresponding CALGB

50801 results (contingent on reaching agreement with CALGB on the combined analysis of the two studies). OUTLINE: This is a multicenter study. Induction ABVD chemotherapy: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV over 3-5 minutes, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients are then assigned to an intervention arm according to fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT) results (negative vs positive).

- ABVD (18FDG-PET/CT negative): Patients receive doxorubicin hydrochloride, bleomycin

sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.

- Escalated or standard BEACOPP* (18FDG-PET/CT positive): Patients receive doxorubicin

hydrochloride IV and cyclophosphamide IV over 60 minutes on day 1, etoposide IV over 60 minutes on days 1-3, procarbazine hydrochloride orally (PO) on days 1-7, prednisone PO on days 1-14, and bleomycin sulfate IV and vincristine sulfate IV on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Within 3-6 weeks after completion of chemotherapy, patients who achieve complete response with a negative 18FDG-PET/CT scan undergo INRT 5 days a week for approximately 3½ weeks. NOTE: *HIV-positive patients whose 18FDG-PET/CT scans are positive after two courses of induction ABVD receive 4 courses of standard BEACOPP followed by INRT. Patients undergo 18FDG-PET scans at baseline, and within 8-10 days after 2 courses of ABVD induction chemotherapy. Patients also undergo 18FDG-PET/CT** scan within 3-8 weeks after completion of 4 courses of BEACOPP and 6 courses of ABVD, and 3 months after completion of INRT. NOTE: **If PET/CT remains positive, then a biopsy may be performed if medically appropriate or clinically feasible at the discretion of the treating physician. If biopsy is positive, patients will be followed for survival and secondary malignancies or new primaries. Patients may undergo blood sample collection for correlative studies. After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 10 years.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically proven classical Hodgkin lymphoma subclassified according to the World

Health Organization (WHO) Classification of Tumors, 4th edition (2008)

- Nodular lymphocyte-predominant Hodgkin lymphoma is excluded

- Patients must have clinical stage IA, IB, IIA, or IIB disease

- Patients with "E" extensions will be eligible if all other criteria have been

met

- Patients must have a mediastinal mass > 0. 33-cm maximum intrathoracic diameter on

standing postero-anterior chest x-ray or measuring > 10 cm in its largest diameter on axial CT images

- Bone marrow biopsy is required

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- ANC ≥ 1,000/μL

- Platelet count ≥ 100,000/μL

- Hemoglobin ≥ 10 g/dL

- Serum creatinine ≤ 2 mg/dL

- Direct bilirubin ≤ 2 mg/dL

- AST/ALT ≤ 2 times upper limit of normal

- Not pregnant or nursing

- Negative pregnancy test

- Women of childbearing potential and sexually active males must be strongly advised to

use an accepted and effective method of contraception

- No "currently active" second malignancy other than non-melanoma skin cancers

- Patients are not considered to have a "currently active" malignancy if they have

completed therapy and are considered by their physician to be at less than 30% risk of relapse

- LVEF by ECHO or MUGA normal unless thought to be disease related

- DLCO ≥ 60% with no symptomatic pulmonary disease unless thought to be disease related

- Patients with a history of intravenous drug abuse, or any behavior associated with an

increased risk of HIV infection, should be tested for exposure to the HIV virus, and an HIV test is required for entry on this protocol

- HIV-positive patients are eligible if they have CD4 counts ≥ 400/mm³ and are on

concurrent antiretrovirals

- Patient HIV status must be known prior to registration

- HIV-positive patients must not have multi-drug resistant HIV infections; CD4

counts < 400/mm³; or other concurrent AIDS-defining conditions PRIOR CONCURRENT THERAPY:

- No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma

- Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³)

allowed

Locations and Contacts

Stanford Cancer Center, Stanford, California 94305-5824, United States; Recruiting
Clinical Trials Office - Stanford Cancer Center, Phone: 650-498-7061, Email: cctoffice@stanford.edu

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center, Reading, Pennsylvania 19612-6052, United States; Recruiting
Clinical Trials Office - McGlinn Family Regional Cancer Center, Phone: 610-988-9323

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: April 2012
Last updated: July 12, 2012

Page last updated: August 23, 2015

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