A Trial of ABI-007 Versus Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00864253 |
Recruitment Status
:
Completed
First Posted
: March 18, 2009
Results First Posted
: June 5, 2014
Last Update Posted
: April 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Malignant Melanoma | Drug: ABI-007 Drug: Dacarbazine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 529 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Multicenter, Phase III Trial of ABI-007 vs Dacarbazine in Previously Untreated Patients With Metastatic Malignant Melanoma |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | February 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: ABI-007
Treatment Arm A (ABI-007): Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
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Drug: ABI-007
Patients who receive ABI-007 will be dosed intravenously over approximately 30 minutes without steroid pre-medication and without G-CSF prophylaxis (unless modified as described below). ABI-007 150 mg/m2 will be administered on Days 1, 8, and 15 every 4 weeks.
Other Name: Abraxane
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Active Comparator: Dacarbazine
Treatment Arm B (dacarbazine): Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
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Drug: Dacarbazine
Patients who receive dacarbazine will be dosed intravenously at 1000 mg/m2 on Day 1 with steroid and antiemetic pre-medication. Treatment will be repeated every 21 days.
Other Name: Dtic-Dome, DTIC-Dome
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- Progression Free Survival (PFS) Based on a Blinded Radiology Assessment of Response Using Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines [ Time Frame: Response assessment completed every 8 weeks until disease progression for up to 106 weeks; data cut off 30 June 2012 ]PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, participants who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free. RECIST defines progressive disease as a ≥ 20% increase taking as reference the smallest sum of the longest diameters recorded since the treatment began.
- Participant Survival [ Time Frame: Up to 38 months; Up to data cut off of 30 June 2012 ]Survival was defined as the time from the date of randomization to the date of death (any cause). Participants were censored at the last known time that they were alive.
- Summary of Treatment-emergent Adverse Events (AEs) [ Time Frame: Maximum exposure to study drug was 106 weeks; up to data cut off of 30 June 2012 ]
A Treatment Emergent AE (TEAE) was any AE that began or worsened after the start of the study drug through 30 days after the last dose of study drug or end of study whichever is later. A treatment related toxicity was one considered by the investigator to be possibly, probably or definitely related to study drug. AE's were graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V 3.0 criteria and the following scale:
Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life threatening, and Grade 5 = Death A SAE is any untoward medical occurrence at any dose that is fatal or life threatening, results in persistent or significant disability or incapacity; requires prolonged hospitalizations; is a congenital anomaly birth defect in the offspring of a patient, and conditions not included in the above that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above.
- Number of Participants Experiencing Dose Reductions, or Dose Interruptions, or Dose Delays of Study Drug [ Time Frame: Maximum study drug exposure 106 weeks; data cut off 30 June 2012 ]The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
- Nadir for the Absolute Neutrophil Count (ANC) Measurements [ Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012 ]Maximal degree of myelosuppression during study drug dosing was represented by the nadir in ANC measurements over all treatment cycles.
- Nadir for White Blood Cells (WBCs) Measurements [ Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012 ]Maximal degree of myelosuppression was represented by the nadir in white blood cells (WBCs) count measurements over all treatment cycles.
- Nadir for Platelet Count Measurements. [ Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012 ]Maximal degree of myelosuppression was represented by the nadir in platelet count measurements over all treatment cycles.
- Nadir for the Hemoglobin Count Measurements [ Time Frame: Day 1 up to 106 weeks; up to data cut off 30 June 2012 ]Maximal degree of myelosuppression during study drug dosing was represented by the nadir in hemoglobin count measurements over all treatment cycles.
- Pharmacokinetic Parameters [ Time Frame: On Cycle 1, Day 1 blood samples were taken at 0.25, 3.5, and 24 hr post-infusion end of the initial dose ]
- Progression-free Survival (PFS) Based on Investigator Assessment Using RECIST Response Guidelines [ Time Frame: Response assessments completed every 8 weeks until disease progression; up to data cut off 30 June 2012; 38 months ]PFS was defined as the time from the randomization date to the start of disease progression or patient death, whichever occurred first. Participants who did not have disease progression or had not died were censored at the last known time that the patient was progression free. In the event of palliative radiotherapy or surgery, they were censored at the last assessment where they were documented to be progression-free prior to the date of radiotherapy or surgery. In follow up, patients who began new anticancer therapy prior to documented progression were censored at the last assessment where they were documented as progression free. Those with two or more missing response assessments prior to a visit with documented disease progression (or death) were censored at the last visit where they were documented to be progression free.
- Percent of Participants Who Achieve an Objective Confirmed Complete or Partial Response Based on Blinded Radiology Assessment of Response by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 [ Time Frame: every 8 weeks; up to data cut off 30 June 2012 ]RECIST defines complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits.
- Percent of Participants With Stable Disease (SD) for ≥ 16 Weeks, or Confirmed Complete or Partial Response (i.e., Disease Control) Based on a Blinded Radiology Assessment of Response [ Time Frame: Response assessment completed every 8 weeks until disease progression; up to data cut-off 30 June 2012 ]
Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #4 for definitions of CR and PR.
RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
- Duration of Response (DOR) in Responding Participants [ Time Frame: up to data cut off 30 June 2012 ]Duration of response (DOR) as measured by PFS based on radiological review for participants who achieved an objective confirmed response of CR or PR. DOR was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or participants death from any cause, whichever occurred first. Participants that did not have progression or had not died were censored at the last known time the participant was progression free. Participants that had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) are defined in outcome #4. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically or cytologically confirmed cutaneous malignant melanoma with evidence of metastasis (Stage IV).
- No prior cytotoxic chemotherapy for metastatic malignant melanoma is permitted. Prior treatment with kinase inhibitors or cytokines is permitted.
- No prior adjuvant cytotoxic chemotherapy is permitted. Prior adjuvant therapy with interferon, Granulocyte-macrophage colony-stimulating factor (GM-CSF) and/or vaccines is permitted.
- Male or non-pregnant and non-lactating female, and ≥ 18 years of age. If a female patient is of child-bearing potential, as evidenced by regular menstrual periods, she must have a negative serum pregnancy test Beta human chorionic gonadotropin (ß-hCG) within 72 hours prior to first study drug administration. If sexually active, the patient must agree to utilize contraception considered adequate and appropriate by the investigator.
- No other current active malignancy within the past 3 years.
- Radiographically-documented measurable disease (defined by the presence of at least 1 radiographically documented measurable lesion
- Patient has the following blood counts at Baseline:
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9 cells/L;
- platelets ≥ 100 x 10^9 cells/L;
- Hemoglobin (Hgb) ≥ 9 g/dL.
- Patient has the following blood chemistry levels at Baseline:
- Aspartate aminotransferase(AST) glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) ≤ 2.5x upper limit of normal range (ULN); ≤ 5.0 xULN if hepatic metastases present;
- total bilirubin ≤ ULN;
- creatinine ≤ 1.5 mg/dL.
- Lactate Dehydrogenase (LDH) ≤ 2.0 x ULNa
- Expected survival of > 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
Exclusion Criteria:
- History of or current evidence of brain metastases, including leptomeningeal involvement.
- Patient has pre-existing peripheral neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Scale of Grade ≥ 2.
- Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed.
- Patient has a clinically significant concurrent illness.
- Patient is, in the investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
- Patient is currently enrolled, or will enroll in a different clinical study in which investigational therapeutic procedures are performed or investigational therapies are administered while participating in this study. Marker studies or studies evaluating biological correlates are permitted.
- Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864253

United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35243 | |
United States, Arizona | |
AZ Cancer Ctr | |
Scottsdale, Arizona, United States, 85258 | |
Arizona Cancer Center | |
Tucson, Arizona, United States, 85724 | |
United States, Arkansas | |
Genesis Cancer Ctr - Hot Springs | |
Hot Springs, Arkansas, United States, 71913 | |
University of Arkansa for Medical Sciences | |
Little Rock, Arkansas, United States, 72205 | |
United States, California | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
San Diego Pacific Oncology and Hematology Associates | |
Encinitas, California, United States, 92024 | |
Loma Linda University Cancer Center | |
Loma Linda, California, United States, 92354 | |
University of Southern California/Norris Cancer Center | |
Los Angeles, California, United States, 90033 | |
University of CA Los Angeles | |
Los Angeles, California, United States, 90095 | |
St. Mary's Medical Center | |
San Francisco, California, United States, 94117 | |
United States, Colorado | |
University of Colorado Cancer Center | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Baptist Cancer Institute | |
Jacksonville, Florida, United States, 32207 | |
Lakeland Regional Cancer Center | |
Lakeland, Florida, United States, 33805 | |
University of Miami Hospital and Clincs/SCCC | |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Waren Billhartz Cancer Center | |
Maryville, Illinois, United States, 62062 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Iowa | |
IA Blood and Cancer Care, PLC | |
Cedar Rapids, Iowa, United States, 52402 | |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | |
Boston, Massachusetts, United States, 02215 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48201 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Saint Louis University | |
Saint Louis, Missouri, United States, 63110 | |
St. John's Medical Research | |
Springfield, Missouri, United States, 65807 | |
United States, Nevada | |
Nevada Cancer Institute | |
Las Vegas, Nevada, United States, 89135 | |
United States, New Jersey | |
Atlantic Melanoma Center | |
Morristown, New Jersey, United States, 07962 | |
United States, North Carolina | |
Piedmont Hematology | |
Winston-Salem, North Carolina, United States, 27103 | |
United States, Ohio | |
OH State University Arthur G. James Cancer Hospital | |
Columbus, Ohio, United States, 43210 | |
United States, Oklahoma | |
Integris Cancer Institute of OK | |
Oklahoma City, Oklahoma, United States, 73142 | |
United States, Pennsylvania | |
St. Luke's Hospital & Health Network | |
Bethlehem, Pennsylvania, United States, 18015 | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19131 | |
United States, Texas | |
Mary Crowley Research Center | |
Dallas, Texas, United States, 75246 | |
Univ of TX MD Anderson Cancer Ctr | |
Houston, Texas, United States, 77030 | |
Univ of TX Med School at Houston | |
Houston, Texas, United States, 77030 | |
Covenant Health System DBA Joe Arrington Cancer Research and Treatment Center | |
Lubbock, Texas, United States, 79410 | |
Hope Oncology | |
Richardson, Texas, United States, 75080 | |
United States, Utah | |
Utah Cancer Specialist | |
Salt Lake City, Utah, United States, 84106 | |
United States, Washington | |
Univ. of Washington Medical Center/Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 | |
Evergreen Hematology & Oncology | |
Spokane, Washington, United States, 99218 | |
Australia, New South Wales | |
Port Macquarie Base Hospital | |
Port Macquarie, New South Wales, Australia, 2444 | |
Royal North Shore Hospital | |
Sydney, New South Wales, Australia, 2065 | |
Sydney West Cancer Trials Centre/Westmead Hospital | |
Westmead, New South Wales, Australia, 2145 | |
Australia, South Australia | |
Royal Adelaide Hospital, Department of Medical Oncology | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Tasmania | |
Royal Hobart Hospital | |
Hobart, Tasmania, Australia, 7000 | |
Australia, Victoria | |
Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | |
Nedlands Perth, Western Australia, Australia | |
Royal Perth Hospital | |
Perth, Western Australia, Australia, 6000 | |
Canada, Alberta | |
Tom Baker Cancer Centre | |
Calgary, Alberta, Canada, T2N 4N2 | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Canada, British Columbia | |
BCCA Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
BCCA, Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
BC Cancer Agency-Fraser Valley Ctr. | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
BC Cancer Agency-Vancouver | |
Vancouver, British Columbia, Canada, V5Z4E6 | |
BC Cancer Agency-Vancouver Island Ctr. | |
Victoria, British Columbia, Canada, V8R 6V5 | |
Canada, Ontario | |
London Regional Cancer Program | |
London, Ontario, Canada, N6A 4L6 | |
Credit Valley Hospital | |
Missiauga, Ontario, Canada, L5M 2N1 | |
The Ottawa Hospital Regional Cancer Centre | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
Canada, Quebec | |
McGill University Dept. of Oncology Clinical Research Program | |
Montreal, Quebec, Canada, H2W 1S6 | |
France | |
Hopital Saint Andre' CHU de Bordeaux | |
Bordeaux, France, 33075 | |
Centre Hospitaller Universitaire de Grenoble | |
Grenoble Cedex 09, France, 38043 | |
CHRU Hopital Claude Huriez | |
Lile cedax, France | |
Hopital Dypuytren-CHU de Limoges | |
Limoges cedex, France | |
Centre Leon Berad | |
Lyon, France | |
Hopital Sainte Marguerite | |
Marseille Cedex 9, France | |
CHU Hopital Saint Eloi | |
Montepellier Cedex 5, France | |
Centre Regional Val d' Aurelle Paul Lamarque | |
Montpellier, France, 34298 | |
Hopital de 1 Archet 2 | |
Nice Cedex 3, France, 06200 | |
Hopital Saint-Louis | |
Paris Cedex, France | |
Hopital Bichat | |
Paris, France, 75018 | |
Groupe hospitalier Cochin-St. Vincent de Paul | |
Paris, France | |
Institut Gustave Roussy (IGR) Centre de Lutte Contre le Canc | |
Villejuif Cedex, France, 94805 | |
Germany | |
Charite Universitaetsmedizin Berlin | |
Berlin, BE, Germany, 10117 | |
Universitaetsklinkum Heidelberg | |
Heidelberg, BW, Germany | |
Universitaetsklinkum Heidelberg | |
Heidelber, BW, Germany | |
Universitaetsklinkum Tuebingen | |
Tuebingen, BW, Germany, 72076 | |
Universitaetsklinkum Wuerzburg PS | |
Wuerzburg, BY, Germany, 97080 | |
Universitaetsklinkum Hamburg-Eppendorf | |
Hamburg, HH, Germany | |
Univeritaetsklinkum Goettingen | |
Gottington, NI, Germany | |
Medizinische Hochschuke Hannover | |
Hannover, NI, Germany, 30625 | |
St. Josef-Hospital | |
Bochum, NW, Germany, 44791 | |
Universitaetsklinkum Essen | |
Essen, NW, Germany | |
Universitaetklinkum Koeln | |
Koln, NW, Germany | |
Universitaetsklinkum Schegwig-Holstein | |
Keil, SH, Germany, 24105 | |
Universitaetsklinkum Dresden | |
Dresden, SN, Germany | |
UniversitawtsklinKum Jena | |
Jena, Strasse 35, Germany, 07743 | |
Universitaesklinkum Leipzig | |
Leipzig, Germany | |
Universitaetsklinkum Mainz | |
Mainz, Germany | |
Italy | |
Istituto Tumori "Giovanni Paolo II" | |
Bari, BA, Italy | |
Istituto Scientifico Romagnolo per lo Studio e la Cura dei T | |
Meldola, FC, Italy, 47014 | |
IST-Istituto Nazionale per la Ricera sul Cancro | |
Genova, GE, Italy, 16132 | |
Istituto Europeo di Oncologia | |
Milano, MI, Italy, 20141 | |
Istituto Nazionale Tumori | |
Milano, MI, Italy | |
IOV-Instituto Oncologico IRCCS | |
Padova, PD, Italy, 35128 | |
Azienda Ospedaliera Universitaria Sense | |
Siena, SI, Italy, 53100 | |
Ist. Naz. per lo studio e la cura dei tumori G. Pascale | |
Napoli, Italy, 80131 | |
Ospedale S. Chiara | |
Pisa, Italy, 56100 | |
Netherlands | |
Medisch Centrum Alkmaar | |
Alkmaar, Netherlands, 1815 | |
Rijnstate ziekenhuis Arnhem | |
Amhem, Netherlands, 6800TA | |
Erasmus MC ae" Daniel den Hoed | |
Rotterdam, Netherlands | |
Spain | |
H Clinic i Provincial | |
Barcelona, Spain, 08036 | |
H CLINIC I Provincial | |
Barcelona, Spain | |
H Clinico San Carlos | |
Madrid, Spain | |
Corporacion Sanitaria Parc Tauli | |
Sabadell, Spain, 08208 | |
United Kingdom | |
Broomfield Hospital | |
Chelmsford, Essex, United Kingdom, CM1 7ET | |
Velindre Hospital | |
Cardiff, Glam, United Kingdom, CF14 2TL | |
St. George's Hospital | |
London, GT Lon, United Kingdom, SW12 ORE | |
Nottingham University Hospitals NHS Trust | |
Nottingham, Nott, United Kingdom, NG5 1PB | |
Singleton Hospital, Sothwest Wales Inst. | |
Swansea, S Glam, United Kingdom, SA28QA | |
Univ Hospital of North Staffordshire | |
Stroke on Kent, Staffs, United Kingdom, ST4 6QB | |
Weston Park Hospital | |
Sheffield, Syorks, United Kingdom, S10 2SJ | |
Newcross Hospital | |
Wolverhampton, Wstmid, United Kingdom, SV10 0QP | |
Royal Marsden Hospital London | |
London, United Kingdom, SW3 6JJ |
Principal Investigator: | Evan Hersh, MD | University of Arizona | |
Study Director: | Ileana Elias, MD | Celgene Corporation |
Publications:
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT00864253 History of Changes |
Other Study ID Numbers: |
CA033 |
First Posted: | March 18, 2009 Key Record Dates |
Results First Posted: | June 5, 2014 |
Last Update Posted: | April 26, 2017 |
Last Verified: | April 2017 |
Keywords provided by Celgene:
Melanoma Malignant Abraxane |
ABI-007 Dacarbazine Dtic-Dome |
Additional relevant MeSH terms:
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Albumin-Bound Paclitaxel Paclitaxel |
Dacarbazine Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |