Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Condition: Lymphoma, Hodgkin Disease; Lymphoma; Hodgkin Disease; Lymphoma: Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma
           with a favorable prognosis treated with "Stanford V-C" chemotherapy comprising
           cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and
           etoposide with low-dose radiotherapy (RT).

        -  Minimize the early and late effects of treatment in these patients by avoiding staging
           laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing
           the dose of RT to moderately bulky sites of disease.

        -  Assess early and late treatment-related toxicity, freedom from second disease
           progression, and overall survival at 5 and 10 years in patients treated with this
           regimen.

      Participants receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30 to 60
      minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly
      on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1 to 8; vincristine IV, and
      bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60
      minutes on days 1 and 2 of weeks 3 and 7. Prior to protocol amendment, participants were
      assigned to treatment on the basis of tumor size (< 5 cm vs 5 to 10 cm), with only the
      participants with larger tumors receiving RT. Beginning 2 to 3 weeks after completion of
      chemotherapy, participants in the +RT group will receive low-dose radiotherapy 5 days a week
      for approximately 3 weeks. Subsequent to amendment, all participants received RT.

      Participants are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.
    

Intervention name(s): Vincristine; Cyclophosphamide; Doxorubicin; Prednisone; Bleomycin; Etoposide; Low-dose radiotherapy (RT)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Radiation
Intervention description(s): 1.4 mg/m² intravenously (IV) on week 2, 4, 6, 8; 650 mg/m², on week 1 and 5; 25 mg/m², on week 1, 3, 5, 7; 40 mg/m², oral, every other day. Taper-reduction 10 mg/m² every other day during last 2 weeks of chemotherapy; 5 u/m² intravenously (IV) on week 2, 4, 6, 8; 60 mg/m² x 2 intravenously (IV) on week 3, 7 (d 15, 16, 43, 44); 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.
Other intervention name(s): Vinblastine; Leurocristine sulfate; Oncovin; Vincasar; LCR; VCR; Vincristin; Vincristina; Vincristinum; 22-Oxovincaleukoblastin; 22-Oxovincaleukoblastine; 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; 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; 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; Bleomycin A2; Bleomycine; Bleocin; Bleomicin; Bleomicina; Bleomycinum; BLM; 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
Intervention MeSH terms: Prednisone; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Etoposide; Etoposide phosphate; Vincristine; Bleomycin; Vinblastine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment