WARNING
It is recommended that DTIC-Dome (dacarbazine) be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
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Hemopoietic depression is the most common toxicity with DTIC-Dome (See Warnings).
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Hepatic necrosis has been reported (See Warnings).
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Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals.
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In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.
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DTIC-DOME SUMMARY
DTIC-Dome Sterile (dacarbazine) is a colorless to an ivory colored solid which is light sensitive. Each vial contains 100 mg of dacarbazine, or 200 mg of dacarbazine (the active ingredient), anhydrous citric acid and mannitol. DTIC-Dome is reconstituted and administered intravenously (pH 3-4). DTIC-Dome is an anticancer agent.
DTIC-Dome is indicated in the treatment of metastatic malignant melanoma. In addition, DTIC-Dome is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other effective agents.
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NEWS HIGHLIGHTS
Published Studies Related to Dtic-Dome (Dacarbazine)
Randomized phase 2/3 trial of CpG oligodeoxynucleotide PF-3512676 alone or with dacarbazine for patients with unresectable stage III and IV melanoma. [2009.09.01]
BACKGROUND: The primary objective of this phase 2 study was to assess the objective response rate (complete response [CR] + partial responses [PR]), by Response Evaluation Criteria in Solid Tumors, of PF-3512676, a CpG oligodeoxynucleotide, alone in 2 doses or in combination with dacarbazine (DTIC) in patients with unresectable stage IIIB/C or stage IV malignant melanoma, with the aim of selecting an arm to take forward to a phase 3 portion of the study... CONCLUSIONS: PF-3512676 at the doses used was generally well tolerated. The modest objective response rates observed in all arms did not warrant continuation to the phase 3 portion of the study.
Early versus late intensification for patients with high-risk Hodgkin lymphoma-3 cycles of intensive chemotherapy plus low-dose lymph node radiation therapy versus 4 cycles of combined doxorubicin, bleomycin, vinblastine, and dacarbazine plus myeloablative chemotherapy with autologous stem cell transplantation: five-year results of a randomized trial on behalf of the GOELAMS Group. [2008.12.15]
BACKGROUND: The 5-year freedom from treatment failure (FFTF) rate, with treatment failure defined as the lack of post-treatment complete remission (CR), recurrence, or death, ranges from 60% to 70% after 6 to 8 cycles of combined doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), which is the reference treatment for patients with advanced Hodgkin lymphoma (HL). In this randomized, phase 2 study, the authors tested 2 intensive chemotherapy regimens in 158 patients with clinical stage (CS) IIB through IV HL accompanied by high-risk factors who were recruited between May 1997 and December 2004... CONCLUSIONS: Early intensification (Arm V) and late intensification (Arm A) were equally effective for treating patients with high-risk/advanced HL.
Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. [2008.12.10]
PURPOSE: Phase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit. In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup... CONCLUSION: Although BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses. Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma.
Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group. [2008.05.01]
PURPOSE: This phase II study evaluated the efficacy and safety of sorafenib plus dacarbazine in patients with advanced melanoma... CONCLUSION: Sorafenib plus dacarbazine was well tolerated in patients with advanced melanoma and yielded an encouraging improvement in PFS. Based on these findings, additional studies with the combination are warranted in this patient population.
Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial. [2007.08.10]
PURPOSE: To investigate whether combined-modality treatment (CMT) with two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by extended-field radiotherapy (EF-RT) is superior to EF-RT alone in patients with early favorable Hodgkin's lymphoma (HL)... CONCLUSION: CMT consisting of two cycles of ABVD plus EF-RT is more effective than EF-RT alone.
Clinical Trials Related to Dtic-Dome (Dacarbazine)
Dacarbazine and Ipilimumab vs. Dacarbazine With Placebo in Untreated Unresectable Stage III or IV Melanoma [Active, not recruiting]
The purpose of this clinical research study is to examine the safety and effectiveness (how
well the drug works) of two different treatments for patients with melanoma. One treatment
is an investigational compound (a drug that is not currently approved by the United States
Food and Drug Administration [FDA]), know as ipilimumab (also known as MDX-010 or BMS-734016)
together with an approved chemotherapy drug called dacarbazine
Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267AM2)(COMPLETED) [Completed]
The purpose of this study is to ascertain if the extended schedule of Temozolomide, which
allows increased doses and potential depletion of the enzyme underlaying resistance, is a
more effective treatment of metastatic melanoma than single agent dacarbazine.
Trial of Dacarbazine With or Without Genasense in Advanced Melanoma [Recruiting]
This study is being performed to prospectively determine whether dacarbazine plus Genasense
is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with
advanced melanoma and low baseline LDH (LDH less than or equal to 0. 8 times the upper limit
of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial
of dacarbazine plus Genasense.
A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma [Recruiting]
The main purpose of this research study is to compare the safety, tolerability, and anti
tumor activity of an investigational drug, ABI-007 versus Dacarbazine in patients with
metastatic melanoma who have not previously received chemotherapy. ABI-007 is a new
preparation of the active drug paclitaxel. It contains the same medication as the
prescription chemotherapy drug Abraxane®. Abraxane® is approved by the FDA for the
treatment of metastatic breast cancer after failure of combination chemotherapy for
metastatic disease or relapse within 6 months of adjuvant chemotherapy. Dacarbazine is
approved by the FDA for the treatment of melanoma. In this study, ABI-007 and Dacarbazine
will be tested as therapy for people who have not yet had any cancer treatment for the
diagnosis of metastatic melanoma.
Comparison of AZD6244 in Combination With Dacarbazine Versus (vs) Dacarbazine Alone in BRAF Mutation Positive Melanoma Patients [Recruiting]
To assess the efficacy in terms of overall survival of AZD6244 in combination with
dacarbazine, compared with dacarbazine alone, in first line patients with BRAF mutation
positive advanced cutaneous or unknown primary melanoma
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Page last updated: 2009-10-20
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