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

NCT01390584 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: E2410NCT01390584U01CA079778U01CA080098
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival Rate

  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.

  Assessed at 36 months

Secondary Outcomes (8)

• Proportion of Patients Who Are PET Negative After Induction Treatment

  Assessed at end of Cycle 2

• Progression-free Survival at 36 Months Among Patients Who Are PET Positive After Induction Treatment

  Assessed at 36 months

• Complete Response (CR) Rate After Induction Treatment

  Assessed at end of Cycle 2

• Overall Survival

  Assessed at 36 months

• Sites of Relapse Following Combined Modality Treatment

  Assessed at 3, 12, 18, 24 and 36 months after INRT

Study Arms (2)

ABVD + INRT

EXPERIMENTAL

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; Drug: Bleomycin; Drug: Vinblastine; Diagnostic Test: PET; Radiation: INRT; Drug: Dacarbazine

ABVD + BEACOPP + INRT

EXPERIMENTAL

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; Drug: Bleomycin; Drug: Vinblastine; Diagnostic Test: PET; Radiation: INRT; Drug: Dacarbazine; Drug: Etoposide; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Procarbazine; Drug: Prednisone

Interventions

Doxorubicin DRUG

IV

Also known as: Adriamycin R, Rubex R, Adriamycin RDF R, Adriamycin PFS R, hydroxydaunorubicin, hydroxydaunomycin, ADR

ABVD + BEACOPP + INRT; ABVD + INRT

Bleomycin DRUG

IV

Also known as: Blenoxane R, BLM, Bleo

ABVD + BEACOPP + INRT; ABVD + INRT

Vinblastine DRUG

IV

Also known as: Velban R, vinblastine sulfate, vincaleukoblastine, VLB, Velsar R, Alkaban AQ R

ABVD + BEACOPP + INRT; ABVD + INRT

PET DIAGNOSTIC_TEST

fludeoxyglucose F 18 Imaging exam

Also known as: PET/CT

ABVD + BEACOPP + INRT; ABVD + INRT

INRT RADIATION

selective external radiation therapy

ABVD + BEACOPP + INRT; ABVD + INRT

Dacarbazine DRUG

IV

Also known as: DTIC, DTIC-Dome®, DIC, imidazole carboxamide, dimethyl triazeno imidazole carboxamide, NSC # 45388

ABVD + BEACOPP + INRT; ABVD + INRT

Etoposide DRUG

IV

Also known as: VP-16, VePesidÒ, VP-16-213, EPEG, epipodophyllotoxin, NSC #141540

ABVD + BEACOPP + INRT

Cyclophosphamide DRUG

May be given orally, IV push, or by IV infusion

Also known as: CytoxanÒ, NeosarÒ, CTX, CPM

ABVD + BEACOPP + INRT

Vincristine DRUG

IV

Also known as: Oncovin R, Vincasar PFS R, vincristine sulfate, VCR, leucocristine, LCR

ABVD + BEACOPP + INRT

Procarbazine DRUG

PO

Also known as: MatulaneR, Ibenzmethyzin, Natulanar, N-Methylhydrazine

ABVD + BEACOPP + INRT

Prednisone DRUG

PO

Also known as: Deltasone, Orasone, Medicorten, Panasol-S, Liquid-Pred

ABVD + BEACOPP + INRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ECOG-ACRIN Cancer Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Stanford Cancer Center

Stanford, California, 94305-5824, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Doxorubicin; Bleomycin; Vinblastine; Positron Emission Tomography Computed Tomography; Dacarbazine; Etoposide; Podophyllotoxin; Cyclophosphamide; Vincristine; Procarbazine; Prednisone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Lignans; Benzyl Compounds; Benzene Derivatives; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Benzamides; Amides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Study Statistician
• Organization: ECOG-ACRIN Biostatistics Center

eatrials@jimmy.harvard.edu

617-632-3012

Study Officials

• Ranjana Advani, MD

  Stanford University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 11, 2011
• Study Start: May 24, 2013
• Primary Completion: April 9, 2015
• Study Completion: May 18, 2018
• Last Updated: June 29, 2023
• Results First Posted: December 22, 2020

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share

Locations

US (2)