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Biomedical subjects

H Gamm

Publications and source records attributed to H Gamm.

35 records · Page 2Linked to original sources

[Alpha interferon in the therapy of hairy cell leukemia. Results of 3 prospective multicenter studies in West Germany].

Within 19 months of recruitment 51 centers enrolled 84 patients in our prospective multicenter trial for low-dose IFN alpha-2c for HCL (1.2 x 10 IU/m x 28 days s.c.- or lower). Induction therapy of 84 days was followed by maintenance with 2 weekly doses. Patients who reached stage Jansen I or A were then randomized to 2 arms either to receive further IFN or to stop treatment. Reinduction was reinstituted whenever any patient lost Jansen stage A or I. Only 3 patients failed. But enrollment was discontinued when it became apparent that fatalities in splenectomized (SX) patients due to septicemia outnumbered deaths given in the literature. Low-dose IFN administered daily might compromise host defense. Our next study aimed at improving the safety of IFN for SX patients. Pulsatile IFN on 7 consecutive days within a 28-day period was given to all SX patients. A randomization of non-SX patients either to receive daily or pulsatile IFN should provide proof of the efficiency. The intermissions ought to be as suitable for in-vitro investigations as for observations concerning the capacity of IFN to produce 'induction of inducers'. Pulsatile treatment has so far been safe in 13 splenectomized patients. Central diagnostic procedures remained the same during both studies. It seems important to us to use an intermittent schedule for the injection of IFN in SX patients and to restrict splenectomy to selected patients.

Aged↗

[Primary treatment of hairy cell leukemia with low-dose human recombinant interferon-alpha-2c (Hr-IFn alpha 2c) in comparison with therapy following splenectomy. Interferon (IFn-alpha 2c) in HCL before or after splenectomy].

Within less than 14 months of recruitment 32 centers enrolled 97 patients in a multicenter trial for low-dose treatment of hairy cell leukemia (1.2 X 10(6) IU/m2 X 28 days s.c. with dose reduction according to clinically judged improvement) or ultra-low dose treatment (1.2 X 10(5) IU/m2, s.c. daily increasing to a well-tolerated dose) with Hr IFn-2c (arg). Induction therapy was limited to 84 days. Patients who reached the clinical stage Jansen I or A were then randomized to 2 arms either to receive further IFn (1.2 X 10(6) IU/m2 s.c.) twice a week or to be taken off treatment. For both arms induction therapy was reinstituted whenever a patient lost the criteria of Jansen stage A or I. The study included obligatory central diagnostic procedures and several special investigations. During the first year of the study a special problem evolved in the group of 34 patients with recurrent disease after splenectomy. Ten of them died, 9 of septicemia and 1 of bleeding complications, whereas only 1 death occurred in those patients who received IFn before splenectomy. The risk factors and the response to therapy in the two groups will be analyzed in order to define the criteria that will be needed for the proper choice of primary treatment for HCL. It appears important to us to restrict splenectomy to selected patients.

Clinical Trials as Topic↗

A prospective multicenter trial with human recombinant alpha 2c-interferon in hairy cell leukemia before and after splenectomy.

Our multicenter study on the treatment of hairy cell leukemia (HCL) started in December 1984 and the present data cover the time up to June 30, 1986. Ninety-seven patients were enrolled. For induction of response daily doses (6 micrograms) of low dose human recombinant alpha 2c-interferon (arg) was chosen. Further dose reduction (3 micrograms) was possible for patients who improved within the first 3-4 weeks. Patients with known risk factors started at lower doses (0.6 microgram daily). As infections are known to be the main cause of death in HCL, splenectomy was not mandatory before treatment. Thirty-nine patients received treatment with interferon. Nevertheless, infections remained the major cause of death in the study. The protocol did not prevent fatal infections in nine of the 34 splenectomized patients. The regimen proved safe for all but one of the nonsplenectomized patients. According to this experience, new criteria are needed for the choice of primary treatment in HCL. In our opinion splenectomy should become restricted to selected cases.

Antineoplastic Agents↗

Current results of a multicenter trial in multiple myeloma.

257 untreated myeloma patients (stage II and III) were studied in a multicenter trial. The patients were randomized and received MP or VCMP therapy. No differences in remission rate could be found in both therapy arms. After successful remission induction those patients without maintenance therapy relapsed significantly earlier than those patients receiving maintenance therapy. In pilot studies an etoposide therapy was found ineffective and a multidrug therapy (VBAMDex) could induce high remission rates in high risk and pretreated patients.

Antineoplastic Combined Chemotherapy Protocols↗

[The effects of 500 ml 10% hydroxyethyl starch 200/0.5 and 10% dextran 40 on blood volume, colloid osmotic pressure and renal function in human volunteers (author's transl)].

The effects of administration of a new, middle-molecular 10% hydroxyethyl starch 200/0.5 (HAES-steril) were compared to 10% dextran 40 (Rheomacrodex) in 20 hypovolaemic volunteers after withdrawal of 400 ml blood. The total increase of blood volume after 500 ml of 10% hydroxyethyl starch 200/0.5 was 10.19 +/- 1.1 ml/kg (754 ml), after 500 ml of 10% dextran 40 14.10 +/- 1.1 ml/kg (1032 ml), which was significantly higher (p less than 0.01) and in correspondence with the known volume expanding properties of 10% dextran 40. The volume effect after administration of both substances was stable, as demonstrated by the ability to compensate the loss of 400 ml blood for more than 8 hours. The maximal increase of the colloid osmotoc pressure after 10% hydroxyethyl starch 200/0.5 was 5.3 +/- 0.2 mm Hg, after 10% dextran 40 7.2 +/- 0.4 mm Hg and paralleled the increase of the blood volume. After 10% hydroxyethyl starch 200/0.5 an increase of serum amylase was observed. This hyperamylasemia is caused by the formation of a high molecular hydroxyethyl starch-amylase complex, which cannot be eliminated easily. Urinary volume and endogenous creatinine clearance were increased by administration of both colloids. After dextran 40 a pronounced increase of the urinary viscosity occurred.

Adult↗

[Tumorscanning of the head and neck malignomas (author's transl)].

Tumorscanning of malignomas and their metastatic nodules in head and neck is an enrichment of diagnostic possibilities. For the examination such substances can be used, which are tumoraffine and well to mark with a radio-isotope. Therefore we have marked the cytostatic drug Bleomycine with 57Co. Scans were performed with the Anger-Camera 4 to 6 hrs after intravenous injection of 1 mCi 57Co-Bleomycine. 60 patients with different malignomas have been examined, 46 with tumor-localization in head and neck, the others in thoraxabdomen. 34 (85%) of the head and neck malignomas could be demonstrated; 21 (81%) were squamous cell carcinomas, 13 (69%) sarcomas. The possibilities of this method are shown; its clinical importance lies in the identification of primary tumors and their metastatic nodules, of relapses and tumorrests as well as the localization of distant metastasises.

Aged↗

Outcome of peripheral blood stem cell mobilization in advanced phases of CML is dependent on the type of chemotherapy applied.

High-dose chemotherapy with autologous transplantation of in vivo purged PBSC is a novel investigational approach to treating chronic myelogenous leukemia (CML) patients not responsive to conventional therapy with interferon-alpha (IFN-alpha) and not eligible for allogeneic transplantation. PBSC mobilization using either '5+2/7+3'-type chemotherapy or 'mini-ICE/ ICE' chemotherapy was investigated in 43 patients with advanced phases of Philadelphia (Ph)-positive CML. Thirty patients were in late chronic phase (>12 months post diagnosis) and 13 patients in accelerated phase (AP) or blast crisis (BC). Contamination with Ph-positive cells was evaluated in harvests from 37/43 patients. The outcome of PBSC mobilization was dependent on the type of chemotherapy administered: a complete or major cytogenetic response (<35% Ph-positive metaphases) in leukapheresis collections was obtained in ten of 15 patients treated with 'mini-ICE/ICE' but in only three of 28 patients treated with '5 + 2/7 + 3' chemotherapy. One patient (1/43) in blast crisis died during mobilization therapy (2%). Twenty-five patients underwent PBSC transplantation and all of them engrafted successfully. Transplantation-related mortality was 0%. The data show that in advanced phases of CML the chance of harvesting Ph-negative peripheral blood stem cells depends on the type of chemotherapy used for mobilization.

Adult↗