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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01390584
Recruitment Status : Terminated (slow accrual)
First Posted : July 11, 2011
Results First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Brief 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.


Condition or disease Intervention/treatment Phase
Lymphoma Drug: Doxorubicin Drug: Bleomycin Drug: Vinblastine Diagnostic Test: PET Radiation: INRT Drug: Dacarbazine Drug: Etoposide Drug: Cyclophosphamide Drug: Vincristine Drug: Procarbazine Drug: Prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 2, 2012
Actual Primary Completion Date : April 9, 2015
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ABVD + INRT

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.

PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are negative, patients receive the following treatment.

ABVD + INRT: Patients receive doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine as in induction chemotherapy. Treatment repeats every 28 days for 4 courses. Within 3-6 weeks after completion of chemotherapy, patients undergo involved-node radiotherapy (INRT) 5 days a week for approximately 3½ weeks.

Drug: Doxorubicin
IV
Other Names:
  • Adriamycin R
  • Rubex R
  • Adriamycin RDF R
  • Adriamycin PFS R
  • hydroxydaunorubicin
  • hydroxydaunomycin
  • ADR

Drug: Bleomycin
IV
Other Names:
  • Blenoxane R
  • BLM
  • Bleo

Drug: Vinblastine
IV
Other Names:
  • Velban R
  • vinblastine sulfate
  • vincaleukoblastine
  • VLB
  • Velsar R
  • Alkaban AQ R

Diagnostic Test: PET
fludeoxyglucose F 18 Imaging exam
Other Name: PET/CT

Radiation: INRT
selective external radiation therapy

Drug: Dacarbazine
IV
Other Names:
  • DTIC
  • DTIC-Dome®
  • DIC
  • imidazole carboxamide
  • dimethyl triazeno imidazole carboxamide
  • NSC # 45388

Experimental: ABVD + BEACOPP + INRT

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.

PET-CT scan: Then patients undergo fludeoxyglucose F 18 (18 FDG) positron emission tomography (PET)/computed tomography (CT). If results are positive, patients receive the following treatment.

BEACOPP + INRT: 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. 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.

Drug: Doxorubicin
IV
Other Names:
  • Adriamycin R
  • Rubex R
  • Adriamycin RDF R
  • Adriamycin PFS R
  • hydroxydaunorubicin
  • hydroxydaunomycin
  • ADR

Drug: Bleomycin
IV
Other Names:
  • Blenoxane R
  • BLM
  • Bleo

Drug: Vinblastine
IV
Other Names:
  • Velban R
  • vinblastine sulfate
  • vincaleukoblastine
  • VLB
  • Velsar R
  • Alkaban AQ R

Diagnostic Test: PET
fludeoxyglucose F 18 Imaging exam
Other Name: PET/CT

Radiation: INRT
selective external radiation therapy

Drug: Dacarbazine
IV
Other Names:
  • DTIC
  • DTIC-Dome®
  • DIC
  • imidazole carboxamide
  • dimethyl triazeno imidazole carboxamide
  • NSC # 45388

Drug: Etoposide
IV
Other Names:
  • VP-16
  • VePesidÒ
  • VP-16-213
  • EPEG
  • epipodophyllotoxin
  • NSC #141540

Drug: Cyclophosphamide
May be given orally, IV push, or by IV infusion
Other Names:
  • CytoxanÒ
  • NeosarÒ
  • CTX
  • CPM

Drug: Vincristine
IV
Other Names:
  • Oncovin R
  • Vincasar PFS R
  • vincristine sulfate
  • VCR
  • leucocristine
  • LCR

Drug: Procarbazine
PO
Other Names:
  • MatulaneR
  • Ibenzmethyzin
  • Natulanar
  • N-Methylhydrazine

Drug: Prednisone
PO
Other Names:
  • Deltasone
  • Orasone
  • Medicorten
  • Panasol-S
  • Liquid-Pred




Primary Outcome Measures :
  1. Progression-free Survival Rate [ Time Frame: Assessed at 36 months ]
    Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.


Secondary Outcome Measures :
  1. Proportion of Patients Who Are PET Negative After Induction Treatment [ Time Frame: Assessed at end of Cycle 2 ]
  2. Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment [ Time Frame: Assessed at 36 months ]
    Progression-free survival is defined as the time from study entry to lymphoma progression or death from any cause. Proportion of patients who are progression-free and alive at 36 months will be reported. Progression is defined as appearance of any new lesions more than 1.5 cm in any axis, at least a 50% increase from nadir in sum of the product of the diameters (SPD) of any previously involved nodes or extranodal masses or the size of other lesions, or at least 50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.

  3. Complete Response (CR) Rate After Induction Treatment [ Time Frame: Assessed at end of Cycle 2 ]
    Complete response (CR) is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy.

  4. Overall Survival [ Time Frame: Assessed at 36 months ]
    Overall survival is defined as the time from study entry to death or date last known alive.

  5. Sites of Relapse Following Combined Modality Treatment [ Time Frame: Assessed at 3, 12, 18, 24 and 36 months after INRT ]
  6. Serum and Plasma Banking [ Time Frame: Baseline and post cycle 2 ]
    To bank serum and plasma at baseline and follow-up time point to assess the prognostic value of various markers, such as but not limited to, SCD30, IL10, CCL17, CCL22, and MDC.

  7. Biomarker Assessment Using Tissue Microarrays (TMAs) [ Time Frame: Baseline and relapse/progression ]
    To create TMAs from patient tumor blocks for future biomarker assessment including but not limited to bcl-2, FOXP3, and macrophage content.

  8. The Association Between Thymus and Activation-related Chemokine (TARC) Levels and PET-CT Findings as Well as 3-year PFS [ Time Frame: Baseline and cycle 2 for TARC assessments; 3 years for PFS ]
    To measure serum TARC levels pre-treatment and after two cycles of ABVD and evaluate the associations between TARC levels and PET-CT findings as well as 3-year PFS.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven classical Hodgkin lymphoma subclassified according to the World Health Organization (WHO) Classification of Tumors, 4th edition (2008)
  • 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
  • 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
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
  • 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
  • Concurrent antiretroviral therapy for HIV-positive patients (CD4 counts ≥ 400/mm³) allowed

Exclusion Criteria:

  • Nodular lymphocyte-predominant Hodgkin lymphoma
  • Pregnant or nursing
  • "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
  • Prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390584


Locations
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United States, California
Stanford Cancer Center
Stanford, California, United States, 94305-5824
United States, Pennsylvania
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Study Chair: Ranjana Advani, MD Stanford University
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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT01390584    
Other Study ID Numbers: E2410
U01CA079778 ( U.S. NIH Grant/Contract )
U01CA080098 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2011    Key Record Dates
Results First Posted: December 22, 2020
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Dacarbazine
Doxorubicin
Liposomal doxorubicin
Etoposide
Vincristine
Etoposide phosphate
Bleomycin
Vinblastine
Podophyllotoxin
Procarbazine
Imidazole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists