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Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Clinical research trials and Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia. Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia clinical trial. Subjects often receive the most expert healthcare possible for their Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia  Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
For Condition: adult acute myeloid leukemia,Drug Toxicity
Status: Completed
Sponsor(s): Kimmel Cancer Center (KCC) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in treating patients with newly diagnosed acute myeloid leukemia who are receiving idarubicin plus cytarabine.
Details: OBJECTIVES: - Determine whether amifostine provides systemic protection against the nonhematologic side effects of idarubicin (IDR) during induction therapy of acute myeloid leukemia (AML), allowing the dose of idarubicin to be escalated. - Determine the maximum tolerated dose of idarubicin when amifostine is used as a chemotherapy protectant. - Determine the incidence and severity of dose limiting hypotension in patients receiving amifostine and the ability to offset this side effect with vasoconstrictive agents. - Determine whether any additional side effects of amifostine are dose limiting in patients with AML treated with IDR and cytarabine (ARA-C). - Monitor the frequency of alopecia, mucositis, diarrhea, and septicemia involving enteric pathogens in these patients. - Determine the requirement for intravenous hyperalimentation in patients receiving amifostine, IDR, and ARA-C. OUTLINE: This is a dose escalation study of idarubicin (IDR). Patients receive amifostine IV over 15 minutes, followed 15-30 minutes later by chemotherapy. Idarubicin IV is administered over 15 minutes on days 1-3. Cytarabine is administered by continuous infusion on days 1-7. Patients may receive 1 additional course of treatment, if necessary. Cohorts of 3-6 patients each are treated at each dose level of idarubicin. Dose escalation is discontinued when 2 or more patients experience dose limiting toxicity. Patients are followed at 3 months. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed acute myeloid leukemia (AML) - M0-M2, M4-M7 - Histologically proven by bone marrow aspirate and biopsy (requirement may be waived for patients with overt leukemia in the peripheral blood) - M3 (acute promyelocytic leukemia) patients excluded unless already treated with trans retinoic acid - Evaluable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Not specified Hepatic: - SGOT/SGPT no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - Ejection fraction at least 50% - Must be able to stop taking antihypertensive medication 24 hours prior to cytarabine administration Other: - No preexisting severe organ dysfunction - No history of underlying medical or psychiatric illness that may impair the patient's ability to participate in the study - Not pregnant or nursing - Effective contraception required of fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - No prior cytotoxic therapy for AML - No prior amifostine - At least 1 month since chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 1 month since radiotherapy Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NealFlomenberg, Study Chair, Kimmel Cancer Center (KCC)
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Additional Information:
Study ID Numbers: CDR0000066164; TJUH-980407,ALZA-97-040-ii,NCI-V98-1395
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003268
Other Drug Toxicity Studies:
1. Chemotherapy, Amifostine, and Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
2. Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
3. Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
4. Rituximab and Rasburicase in Treating Young Patients With Newly Diagnosed Advanced B-Cell Leukemia or Lymphoma Who Are Receiving Combination Chemotherapy
5. Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
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Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
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