Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

NCT00026208 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB-13081LYMHD0002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This phase 2 trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.

Conditions

Lymphoma, Hodgkin Disease; Lymphoma; Hodgkin Disease; Lymphoma: Hodgkin

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Progression-free survival was assessed for 3 years from the completion of treatment. Progression-free survival was considered to mean the proportion of patients (percentage) still alive without disease recurrence or progression.

  up to 3 years

Secondary Outcomes (6)

• Frequency of Complete Response

  5 weeks

• Early Treatment-related Toxicity

  Within 30 days of treatment

• Late Treatment-related Toxicity

  16 years

• Second Hodgkin's Disease Progression

  16 years

• Overall Survival (OS)

  16 years

Study Arms (2)

Stanford V-C + Low-dose Radiotherapy

EXPERIMENTAL

"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide. Radiotherapy = 20 Gy modified involved field radiotherapy

Drug: Vincristine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Bleomycin; Drug: Etoposide; Radiation: Low-dose radiotherapy (RT)

Stanford V-C only

EXPERIMENTAL

"Sanford V-C" = Vinblastine, cyclophosphamide, doxorubicin, prednisone, bleomycin, + etoposide.

Drug: Vincristine; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone; Drug: Bleomycin; Drug: Etoposide

Interventions

Vincristine DRUG

1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8

Also known as: Vinblastine, Leurocristine sulfate, Oncovin, Vincasar, LCR, VCR, Vincristin, Vincristina, Vincristinum, 22-Oxovincaleukoblastin, 22-Oxovincaleukoblastine

Stanford V-C + Low-dose Radiotherapy; Stanford V-C only

Cyclophosphamide DRUG

650 mg/m², on week 1 and 5

Also known as: Cytoxan, Neosar, Cyclophosphamidum, Cyclophosphamid, Ciclofosfamida, Cytophosphane, Ledoxina, Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester, 2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide, N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide

Stanford V-C + Low-dose Radiotherapy; Stanford V-C only

Doxorubicin DRUG

25 mg/m², on week 1, 3, 5, 7

Also known as: Adriamycin, Doxorubicinum, Doxorubicine, Rubex, Hydroxydaunomycin HCl, Hydroxydoxorubicin HCl, Hydroxydaunorubicin, 14-hydroxydaunomycin, 14-hydroxydaunorubicine, (1S,3S)-3-Glycoloyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1,2,3,4,6,11-hexahydrotetracen-1-yl 3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranoside, (8S-cis)-10-((3-amino-2,3,6-Trideoxy-alpha-L-lyxo-hexopyranosyl)oxy)-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-5,12-naphthacenedione

Stanford V-C + Low-dose Radiotherapy; Stanford V-C only

Prednisone DRUG

40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy

Also known as: Dehydrocortisone, Deltasone, Liquid Pred, Meticorten, Orasone, Prednicot, predniSONE Intensol, Rayos, Sterapred, Prednisona, Prednisonum, 1,2-Dehydrocortisone, 1,4-Pregnadiene-17alpha,21-diol-3,11,20-trione, 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione

Stanford V-C + Low-dose Radiotherapy; Stanford V-C only

Bleomycin DRUG

5 u/m² intravenously (IV) on week 2, 4, 6, 8

Also known as: Bleomycin A2, Bleomycine, Bleocin, Bleomicin, Bleomicina, Bleomycinum, BLM

Stanford V-C + Low-dose Radiotherapy; Stanford V-C only

Etoposide DRUG

60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44)

Also known as: Toposar, Etopophos, Vepesid, VP-16, Etoposido, Etoposidum, trans-Etoposide, 4-demethylepipodophyllotoxin β-D-ethylideneglucoside, 4'-Demethylepipodophyllotoxin 9-(4,6-O-(R)-ethylidene-beta-D-glucopyranoside), 9-((4,6-O-Ethylidine-beta-D-glucopyranosyl)oxy)-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,4-dimethyloxyphenyl)furo(3',4'':6,7)naptho-(2,3-d)-1,3-dioxol-6(5aH)-one

Stanford V-C + Low-dose Radiotherapy; Stanford V-C only

Low-dose radiotherapy (RT) RADIATION

20 Grey (Gy) modified involved field radiotherapy administered as consolidative irradiation will beginning between 2 and 12 weeks after the completion of Stanford V-C chemotherapy regimen.

Stanford V-C + Low-dose Radiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of previously untreated stage I or IIA Hodgkin's lymphoma, eligible subtypes
• Nodular sclerosis
• Mixed cellularity
• Classical, not otherwise specified
• Age ≥ 18 years and ≤ 70 years
• Granulocytes ≥ 2 x 10e6/µL
• Platelets ≥ 150 x 10e6/µL
• Bilirubin ≤ 2.5 mg/dL
• Serum creatinine ≤ 2 mg/dL
• Patients \> 50 years or those with a history of cardiac disease should have an ejection fraction ≥ 50%
• All scans, X-rays, laboratory tests must be performed within 6 weeks of enrollment
• Pathologic material reviewed at Stanford University
• Evaluation by Stanford Medical Oncology and Radiation Oncology with review at the Hodgkin's Disease Staging Conference
• Written informed consent

You may not qualify if:

• Lymphocytic predominance Hodgkin's disease
• Prior treatment for Hodgkin's disease
• Mediastinal mass equal to or greater than one-third the maximum intrathoracic diameter on a standing posteroanterior chest x-ray
• Any lymph node mass \> 10 cm in greatest trans-axial diameter
• Two or more extranodal sites of disease
• Constitutional (B) symptoms present at diagnosis
• Prior or concurrent malignancies within 5 years (EXCEPTION: basal cell carcinoma of the skin)
• Any medical contraindication to the planned treatment, including:
• Pregnant
• Positive antibody test for the human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Kaiser Permanente Medical Center

Vallejo, California, 94589, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Vincristine; Vinblastine; Cyclophosphamide; Doxorubicin; Prednisone; Bleomycin; Etoposide; etoposide phosphate; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Therapeutics

Results Point of Contact

• Title: Jessica C Lam, BS
• Organization: Stanford Univeristy Medical Center

jclam11@stanford.edu

650-723-0437

Study Officials

• Ranjana H Advani, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Saul A. Rosenberg, MD, Professor of Lymphoma

Model Details: Patients with tumors 5 to 10 cm were to be assigned to concurrent radiotherapy, and participants with tumors less than 5 cm were initially planned to not receive radiotherapy.

Study Record Dates

• First Submitted: November 9, 2001
• First Posted: January 27, 2003
• Study Start: June 1, 2001
• Primary Completion: April 26, 2013
• Study Completion: February 13, 2017
• Last Updated: July 24, 2018
• Results First Posted: May 15, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)