Phase II evaluation of bolus gallium nitrate in lymphoproliferative disorders: a Southeastern Cancer Study Group trial.

Gallium nitrate was administered as a 700-mg/m2 iv bolus infusion over 15-30 minutes every 2 weeks to 138 patients with malignant lymphoproliferative diseases. Responses occurred in patients with well-differentiated lymphomas (five responses among eight patients), but the drug produced few responses in any other group of patients. Toxic effects were primarily gastrointestinal and reversible renal abnormalities and anemia.

Treatment of chronic lymphocytic leukemia using chlorambucil and prednisone with or without cycle-active consolidation chemotherapy. A Southeastern Cancer Study Group Trial.

Patients with untreated chronic lymphocytic leukemia (CLL) received protocol treatment with 6 months of chlorambucil (CB) (30 mg/M2) and prednisone (P) (80 mg/d X 5) every 2 weeks. Complete and partial responders (CR, PR) were then randomized to consolidation with six more courses of CB and P or to four courses of cytosine arabinoside (25 mg/M2 every 12 hours X 8, subcutaneously) and cyclophosphamide (25 mg/M2 every 12 hours X 8, orally) every three weeks. Of the 178 eligible patients entered, 138 (78%) were evaluable for induction therapy which produced a 22% hematologic CR and an overall response rate (CR + PR) of 74%.

Phase II evaluation of anguidine (NSC 141537) in 5-day courses in colorectal adenocarcinoma. A Southeastern Cancer Study Group Trial.

Thirty-three patients with advanced colorectal adenocarcinoma were treated with daily Anguidine i.v. 5 mg/m2 X 5 for 3 weeks.

Phase I-II evaluation of razoxane (ICRF-159) and doxorubicin in gastrointestinal cancer. A Southeastern Cancer Study Group Trial.

A Phase I-II study of razoxane (ICRF-159) and doxorubicin was undertaken in 34 adults with advanced gastrointestinal carcinoma. Three dose schedules were studied; weekly razoxane at 600 mg/m2 orally plus doxorubicin 60 mg/m2 every 3 weeks, razoxane at 300 mg/m2 plus doxorubicin 60 mg/m2, and weekly razoxane 300 mg/m2 plus doxorubicin 35 mg/m2 every 3 weeks. This combination produced moderate to severe granulocytopenia in 24 patients including granulocytopenia less than or equal to 500/mm3 in 15.

Consolidation and maintenance therapy in multiple myeloma: randomized comparison of a new approach to therapy after initial response to treatment.

A randomized, controlled trial was initiated in 1977 to evaluate the impact of three alternative approaches to consolidation and maintenance therapy after initial maximal response for multiple myeloma. All patients were treated initially with BCNU, cyclophosphamide, and prednisone (BCP) until a designated level of response was achieved. Responders were randomly assigned to either melphalan and prednisone (MP); prednisone, Adriamycin (Adria Laboratories, Columbus, Ohio), azathioprine, and vincristine (PAIV), or no therapy until relapse, then treatment with BCP.

A phase I/II SECSG (Southeastern Cancer Study Group) pilot study of surgical adjuvant immunotherapy with vaccinia melanoma oncolysates (VMO).

Forty-eight patients with nonrecurrent high risk Stage I and II malignant melanoma were treated with Vaccinia Melanoma Oncolysates (VMO). Six different dose levels and two different treatment regimens were tested. Thirty-two out of 48 patients completed the 12 months of therapy.

A Southeastern Cancer Study Group phase I/II trial with vaccinia melanoma oncolysates.

Vaccinia melanoma oncolysates (VMO) were tested in a Southeastern Cancer Study Group (SECSG) Phase I/II trial. Forty-eight patients with high-risk Stage I or pathologic Stage II disease were placed on study at six different dose levels and two different treatment regimens. Patients were monitored for toxicity to the VMO after each injection.

Phase II evaluation of cisplatin, bleomycin, and vindesine in advanced squamous cell carcinoma of the esophagus: a Southeastern Cancer Study Group Trial.

Adults with advanced, measurable, squamous cell carcinoma of the esophagus were treated with a combination of cisplatin, bleomycin, and vindesine. Of 27 evaluable patients, seven (29%) had partial response, all occurring within the first two cycles of therapy. Of 13 patients receiving more than two cycles, only five completed the five planned cycles of therapy and did not progress while receiving the additional three cycles.

Age and the treatment of multiple myeloma. Southeastern Cancer Study Group experience.

To determine the impact of age upon the response to treatment, survival, and toxicity of chemotherapy for multiple myeloma, the results of a large cooperative group trial were examined. Patients were randomly assigned to induction therapy with either carmustine, cyclophosphamide, and prednisone or melphalan and prednisone; patients with response received two years of treatment. The age distribution of patients in this trial compared with the incidence figures from the Surveillance Epidemiology and End Results (SEER) study shows a degree of under-representation of the oldest patient groups.

Phase III study of BCOP v CHOP in unfavorable categories of malignant lymphoma: a Southeastern Cancer Study Group trial.

A total of 296 evaluable patients with unfavorable categories of malignant lymphoma were randomly assigned treatment with cyclophosphamide, vincristine, and prednisone plus BCNU (BCOP) or doxorubicin (CHOP). In diffuse histiocytic (DH) lymphoma, CHOP produced superior complete (54% v 34%) and total (70% v 46%) response rates. Among the responders to either therapy, no differences were seen in duration of response or survival times.

Cisplatin, vinblastine, and bleomycin in the treatment of metastatic melanoma: a phase II study of the Southeastern Cancer Study Group.

Fifty-one patients with metastatic melanoma were treated with cisplatin, vinblastine, and bleomycin. Of the 50 evaluable patients, 11 (22%) achieved an objective response, including three complete (6%) and eight partial (16%) responses. Four of the 11 responding patients had previously received dacarbazine; the remaining patients had received no prior chemotherapy.

Free thyroid hormones in evaluating persistently elevated thyrotropin levels in children with congenital hypothyroidism on replacement therapy.

Some children with congenital hypothyroidism receiving L-T4 therapy have elevated serum TSH levels despite having normal serum T4 concentrations, suggesting that they have a higher threshold for the feedback regulation of TSH release. To further study this possibility, we determined serum free T4 (FT4) and T3 (FT3) concentrations in two groups of L-T4-treated hypothyroid children. Group A consisted of 10 patients with high serum TSH levels; group B consisted of 10 patients with normal TSH levels.

Phase II studies of mitoxantrone (dihydroxyanthracenedione) in the treatment of advanced colorectal carcinoma.

One hundred four patients with advanced colon carcinoma were treated with mitoxantrone 5 mg/m2 I.V. weekly.