Bevacizumab for Melanoma

Phase-Based Estimates
1
Effectiveness
1
Safety
Mayo Clinic, Scottsdale, AZ
Melanoma+67 More
Bevacizumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Melanoma

Study Summary

This study is evaluating the side effects and best dose of nab-paclitaxel and bevacizumab in treating patients with stage IV melanoma that cannot be removed by surgery (unresectable), cancer of the cervix,

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Eligible Conditions

  • Melanoma
  • Cancer
  • Adenocarcinoma
  • Peritoneal Neoplasms
  • Ovary Cancer
  • Carcinoma, Endometrioid
  • Adenocarcinoma, Mucinous
  • Carcinoma, Adenosquamous
  • Carcinoma, Squamous Cell
  • Carcinoma
  • Mixed Tumor, Mullerian
  • Cystadenocarcinoma
  • Genital Neoplasms, Female
  • Carcinosarcoma
  • Adenosarcoma
  • Cystadenocarcinoma, Serous
  • Carcinoma, Transitional Cell
  • Carcinoma, Ovarian Epithelial
  • Adenocarcinoma, Clear Cell
  • Ovarian High Grade Serous Adenocarcinoma
  • Malignant Female Reproductive System Neoplasm
  • Neoplasms
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Mucinous Adenocarcinoma
  • Ovarian Neoplasms
  • Fallopian Tube Serous Adenocarcinoma
  • Cervical Squamous Cell Carcinoma
  • Malignant Peritoneal Neoplasm
  • Ovarian Serous Adenocarcinoma
  • Endometrial Adenosquamous Carcinoma
  • Malignant Ovarian Clear Cell Tumor
  • Primary Peritoneal Serous Adenocarcinoma
  • Uterine Corpus Carcinosarcoma
  • Ovarian Transitional Cell Carcinoma
  • Undifferentiated Ovarian Carcinoma
  • Platinum-Resistant Fallopian Tube Carcinoma
  • Platinum-Sensitive Ovarian Carcinoma
  • Primary Peritoneal Clear Cell Adenocarcinoma
  • Primary Peritoneal Transitional Cell Carcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
  • Stage IV Cutaneous Melanoma AJCC v6 and v7
  • Endometrial Clear Cell Adenocarcinoma
  • Endometrial Endometrioid Adenocarcinoma
  • Endometrial Mucinous Adenocarcinoma
  • Fallopian Tube Squamous Cell Carcinoma
  • Unresectable Melanoma
  • Malignant Ovarian Endometrioid Tumor
  • Endometrial Undifferentiated Carcinoma
  • Fallopian Tube Clear Cell Adenocarcinoma
  • Malignant Ovarian Epithelial Tumor
  • Malignant Ovarian Mucinous Tumor
  • Malignant Solid Neoplasms
  • Adenocarcinoma of the Cervix
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Carcinosarcoma
  • Primary Peritoneal Carcinosarcoma
  • Fallopian Tube Transitional Cell Carcinoma
  • Cervical Adenosarcoma
  • Adenosquamous carcinoma of the cervix
  • Endometrial Serous Adenocarcinoma
  • Cervical Carcinosarcoma
  • Endometrial Mixed Cell Adenocarcinoma
  • Undifferentiated Fallopian Tube Carcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Ovarian Carcinosarcoma
  • Ovarian Clear Cell Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mucinous Adenocarcinoma
  • Platinum-Resistant Ovarian Carcinoma
  • Platinum-Resistant Primary Peritoneal Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Bevacizumab will improve 1 primary outcome and 4 secondary outcomes in patients with Melanoma. Measurement will happen over the course of 28 days.

28 days
Maximum tolerated dose
Month 12
Overall survival (OS)
Month 12
Progression-free survival (PFS)
Up to 12 months
Incidence of adverse events (soft tissue expansion cohort)
Tumor response

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (AB-complex)

This trial requires 73 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bevacizumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (AB-complex)Patients receive nab-paclitaxel/bevacizumab-complex IV over 30-60 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patient may receive paclitaxel if supply of nab-paclitaxel is exhausted.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
FDA approved
Albumin human
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

Mayo Clinic - Scottsdale, AZ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Melanoma or one of the other 67 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Melanoma cohort only: histologic proof of surgically unresectable stage IV malignant melanoma
Melanoma cohort only: measurable disease defined as at least one lesion whose longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with computed tomography (CT) scan or magnetic resonance imaging (MRI) scan; or CT component of a positron emission tomography (PET)/CT; NOTE: disease that is measurable by physical examination only is not eligible
Histologic proof of endometrial cancer including endometrioid, serous, clear cell, mucinous, undifferentiated, mixed, and carcinosarcoma histologies
1-3 lines of cytotoxic or immune checkpoint inhibitor therapy (not including hormonal therapy or other regimens not containing cytotoxic agents or immune checkpoint inhibitors)
If one (1) prior line of therapy, must have contained a taxane, a platinum drug, and and immune checkpoint inhibitor If 2-3 prior lines of therapy, at least one must have contained a taxane and a platinum drug, and at least one must have contained an immune checkpoint inhibitor Histologic proof of ovarian cancer including high grade serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma histologies
Gynecologic cancer cohorts only (dose escalation and dose expansion cohorts)
Dose escalation cohort only: Histologic proof of epithelial cervical, endometrial, ovarian, fallopian, or primary peritoneal cancers; allowable histologies for cervical cancer include squamous cell carcinoma, adenocarcinoma, and mixed/adenosquamous carcinoma; allowable histologies for endometrial cancer include endometrioid, serous, clear cell, mucinous, squamous, transitional cell, undifferentiated, mixed, and carcinosarcoma (this is considered a poorly differentiated epithelial tumor); allowable histologies for ovarian, fallopian, and peritoneal cancer include serous, clear cell, endometrioid, mucinous, transitional cell, undifferentiated, mixed, and carcinosarcoma
1-4 lines of cytotoxic chemotherapy (not including hormonal therapy or other non-cytotoxic regimens)
At least one prior line of chemotherapy must have contained a taxane and a platinum agent
If 1 or 2 prior lines of chemotherapy, patient's disease must be platinum-resistant

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for melanoma?

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In this exploratory study, patients with metastatic melanoma on biologic therapy had an improvement in their overall survival; and, there did not appear to be any difference between patients receiving a BRAF inhibitor and a BRAF inhibitor plus MEK inhibitor combination.

Unverified Answer

What is melanoma?

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Melanoma is one of the two main types of [skin cancer](https://www.withpower.com/clinical-trials/skin-cancer), the other one being basal-cell skin cancer (basal-cell carcinoma), which has a lower rate of metastatic spread and a better life expectancy. One in three deaths from cutaneous cancer is due to melanoma, and this is the eighth most common cause of death in the United States, responsible for more deaths in women than all other types of cancer combined.

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Can melanoma be cured?

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Melanoma is rare and the prognosis very good, even for advanced disease. With modern treatment techniques, local control of cancer is enhanced. However, if the melanoma is in one or more locations or has spread to other parts of the body, the ultimate goal is cure of the cancer.

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What are the signs of melanoma?

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Melanoma is a potentially curable disease, and early diagnosis is the key to cure and improving the quality of life. The most early and specific signs are: itchiness, loss of appetite, skin changes such as roughness or darkening, painless sore/pimple/swelling/lumps/tumours and dark circles/discolorations around the eyes. Other possible signs of melanoma are: loss of hair, rash, eye irritation/pigmentation or swelling.

Unverified Answer

What causes melanoma?

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Melanoma is believed to be caused by UV radiation and is probably driven by a complex interaction of genetics, environment, and epigenetics. In addition, other mechanisms beyond the UV light pathway play a role. Multiple genomic alterations including somatic mutations, alterations in the microRNA (miRNA) or tnA/miRNA pathways have been described in the genetic and molecular background of melanoma. However, the role of genes and non-coding RNA are still poorly understood. This lack of understanding is due, in part, to the observation that many genes and long non-coding DNA sequences are expressed at higher levels or at different stages of cancer development.

Unverified Answer

How many people get melanoma a year in the United States?

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Around 37 million Americans have a lifetime risk of developing the disease (melanoma, non-melanoma skin cancer, and basal cell carcinoma of the skin) that is greater than 20%. This indicates that the number of new cases of melanoma, non-melanoma skin cancer, and, possibly, basal cell carcinomas of the skin that will occur in the United States in the year 2014 is in excess of 200,000. There are two routes of melanoma transmission that may influence the number of cases: familial inheritance, and individual susceptibility. There is no evidence that a third approach - exposure solely to ultraviolet radiation from natural sunlight - plays any significant role. The majority of melanomas arise from sun exposure.

Unverified Answer

What is nab-paclitaxel?

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Nab-Paclitaxel should be given as a second line drug, as a single agent, for patients with a high risk primary tumor and metastatic disease in the regional lymph nodes. For patients whose disease progresses or has metastasized from the nodal basin, paclitaxel may be tried as a second line. To be effective, nab-Paclitaxel should be used with adequate patient selection and meticulous monitoring. The optimal regimen for the treatment of patients with metastatic disease in the liver is yet to be determined. Clinical results in this setting appear promising, and this drug should be examined in larger, controlled studies.

Unverified Answer

Does melanoma run in families?

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If melanoma has a familial predisposition, this is not a common condition. It would appear that the familial pattern of melanoma is not in any way related to a specific mutation in the tyrosinase gene. If the familial pattern did arise as a response to certain environmental factors, it appears that environmental factors have now been eliminated. However, other rare or rare variants may exist which might modify the familial pattern.

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What does nab-paclitaxel usually treat?

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A majority of patients (51%) experience a clinical improvement of symptoms at a median period of 5 weeks. In the event of adverse reactions, nab-paclitaxel is usually withheld in most patients.

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What are the chances of developing melanoma?

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Overall, there was no relationship between the risk of developing melanoma as an adult and the amount of sun exposure or sun protection in childhood. However, an examination of the degree to which the ultraviolet radiation (UVR)-induced DNA damage is repaired within each individual provides an insight into cancer risk. While these results would suggest that sun protection will not prevent melanoma development in a given individual, it is possible that if the individual has a weak ability to repair DNA damage caused by UVR, it is potentially more harmful than beneficial to development of melanoma.

Unverified Answer

What is the primary cause of melanoma?

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Most probable cause is the damage of UVB and UVB from the sun. For more details we must look for the molecular mechanisms of photodynamic (photo-damage to cells), immunostimulation pathways, tumor suppressor genes, and epigenetic modification. I think in our time you already have enough knowledge about all of them and can think for ourselves. Anyway, to avoid complications, in spite of UVB is not enough to explain the melanoma, UVB-induced photodynamic response and the resultant antigenic stress might be just one of many initiating events.

Unverified Answer

How does nab-paclitaxel work?

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I am not sure in what way nab-paclitaxel works but I am almost sure that it does not have an effect on melanoma cells that is comparable (in effectiveness) to cisplatin which is part of standard chemotherapy for melanoma. The clinical usefulness of nab-paclitaxel may be better than what is suggested by the results in melanoma models.

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