Vinblastine Sulfate for Hodgkin Disease

1
Effectiveness
1
Safety
Memorial Sloan Kettering Westchester, Harrison, NY
Hodgkin Disease+2 More
Vinblastine Sulfate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Hodgkin Disease

Study Summary

This study is evaluating whether a combination of chemotherapy and radiation therapy is better than chemotherapy alone.

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Eligible Conditions

  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Hodgkins

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Vinblastine Sulfate will improve 2 primary outcomes and 1 secondary outcome in patients with Hodgkin Disease. Measurement will happen over the course of 1 year.

1 year
Evaluate the prognostic significance
complete responses (all cohorts)
development of significant pulmonary toxicity

Trial Safety

Trial Design

4 Treatment Groups

No Control Group
Cohort 2

This trial requires 118 total participants across 4 different treatment groups

This trial involves 4 different treatments. Vinblastine Sulfate is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Cohort 2Patients with early stage, unfavorable risk Hodgkin lymphoma. The definition of disease bulk, one of the unfavorable risk features, has been updated, and is defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin & AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 & 15 of each 28 day cycle. This may be followed by 20 Gy involved site radiotherapy.
Cohort 3Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. Patients will receive 4 cycles of brentuximab vedotin and AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, and Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30.6 Gy CVRT.
Cohort 1 (completed accrual)Patients received 4 cycles of brentuximab vedotin & AVD chemotherapy. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 and 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, & Dacarbazine 375 mg/m2 will be administered on days 1 and 15 of each 28 day cycle. This may be followed by 30 Gy involved site radiotherapy. Involved site radiotherapy should be initiated from 12 days to 42 days after completion of chemotherapy. It is mandatory to administer prophylactic growth factor support starting with cycle 1. Choice of growth factor and dosing can be determined at the discretion of the treating physican.
Cohort 4Patients will have early stage, unfavorable risk classical Hodgkin lymphoma with disease bulk defined as the presence of any lymph node mass with transverse maximal diameter > 7.0 cm or coronal maximal diameter > 7.0 cm. In this cohort. Pts will receive 4 cycles of brentuximab vedotin & AVD chemo. Brentuximab vedotin, 1.2 mg/kg, will be administered on days 1 & 15 of each 28 day cycle. Doxorubicin 25 mg/m2, Vinblastine 6 mg/m2, & Dacarbazine 375 mg/m2 will be administered on days 1 & 15 of each 28 day cycle. Pts whose PET scan is negative after 4 cycles of brentuximab vedotin & AVD chemotherapy will not receive RT. Pts whose PET scan is positive after 4 cycles of brentuximab vedotin & AVD chemo, but subsequent biopsy is neg, will also receive no RT. Upon MSK PI approval, if the simulation can't be covered by the institution or the pts insurance, a diagnostic IV contrast CT neck & diagnostic IV contrast CT CAP scan will be done in addition to the FDG-PET done after 4 cycles of chemo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vinblastine
FDA approved
Dacarbazine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 year for reporting.

Closest Location

Memorial Sloan Kettering Westchester - Harrison, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Hodgkin Disease or one of the other 2 conditions listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution
FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT
Ann Arbor Stage I or II disease
Disease bulk defined as any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm on CT imaging
Females of childbearing age must be on an acceptable form of birth control per institutional standards
Ages 18 and over

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 the signs of hodgkin disease?

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The patient should think the condition is not uncommon. Some patients become infected, but this only occurs with a T-cell mediated, Epstein-Barr virus-positive form of the disease, in a subset of patients who are genetically predisposed or are otherwise at very-high risk. The disease resolves quickly despite the presence of an active infection or the advent of immune-suppression.

Unverified Answer

What causes hodgkin disease?

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It is important to note that, although this disease most commonly affects males, it is becoming increasingly apparent in young and middle-aged females. While HOD may occur spontaneously, there is evidence to suggest an environmental link from x-ray exposure to development of HOD.

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What are common treatments for hodgkin disease?

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While combination chemotherapy with anthracyclines and other antimetabolites, bleomycin, cyclophosphamide, or vincristine are the most commonly used treatment in the majority of adult cases with an unfavorable prognosis, use of anthracyclines alone has become increasingly common among those with an excellent prognosis. As chemotherapy protocols change and new agents such as bortezomib or bexarotene (PXD/VX) become available, treatment regimens may become more personalized for each patient.

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Can hodgkin disease be cured?

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There are no recent randomized trial and many case series suggesting for HD, more effective treatment is needed as of right now. In fact in the first cases of HD in which no treatment was recommended, many patients did not survive. [Power(http://www.withpower.com/clinical-trials/hodgkin-disease)] will help you find clinical trials targeted against your HD that will be tailored to your HD, treatment, and location.

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How many people get hodgkin disease a year in the United States?

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The incidence of HD is increasing in the US population. This observation supports the concept that the etiology of HD in the United States is different from that reported in other jurisdictions. The incidence rate of HD in all ages is similar to that reported elsewhere; however, the prevalence rate in young whites is five to sixfold lower. In men, the incidence rate of HD has almost doubled among those age 65 years and older in the United States compared with the incidence in other geographical regions.

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What is hodgkin disease?

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There are four types of Hodgkin disease. In each type, there are variations in the cancer cells' genetics, aggressiveness, and appearance. The first is called Mature B-cell lymphoma/leukemia, the second is T-cell lymphoma, the third is lymphomatoid cell lymphoma, and the fourth is a rare form of Hodgkin lymphoma that mostly occurs in Africa and in the Middle East.

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What is the primary cause of hodgkin disease?

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If individuals with Hodgkin disease experience the same symptoms as the population, they are unlikely to be at risk of a viral infection. However, if they do experience symptoms that are unusual, they are more likely to be at risk of an infection.

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Have there been any new discoveries for treating hodgkin disease?

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At present, the only [drug that is available for treating hodgkin disease] licensed for clinical use is vinorelbine used in combination with pegylated liposomal [doxorubicin] (trade name Myocet). summary: This article describes the role of ritonavir in treating a human disease.

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Have there been other clinical trials involving vinblastine sulfate?

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Several Phase II clinical trials have investigated the potential benefit of v.S. on patients with Stage III Hodgkin disease. One of these, which assessed the benefit of v.S. versus vincristine plus bleomycin in patients with Stage III Hodgkin disease, reported a 5 year disease-free survival rate of 66%. Based upon the available evidence, v.S. may be used for patients with Stage III Hodgkin lymphoma, in combination with current therapeutic approaches.

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What is the survival rate for hodgkin disease?

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The overall 5-year cure rate for HD patients was 60% for those with stage I. Stage II patients had a five-year rate of 48% and stage III patients an eight-year rate of 28%. Patients with high-risk features had a poorer survival rate. There is a need to assess the long-term survival rate of these high-risk patients, which is higher in patients treated with ASCT/ACL-B/cRCT. It should be recognized that the improvement in 5-year survival rate in our patients is not related to better treatment of stage IV patients.

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What is the latest research for hodgkin disease?

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This review covers recent research results using new cancer therapies and new clinical trials; thus, it might be useful to surgeons and oncologists to learn the latest research about these therapies.

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How does vinblastine sulfate work?

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Based on the evidence available, researchers could recommend the use of vinblastine sulfate in the treatment of stage II or III Hodgkin's lymphoma in combination with other chemotherapy agents based on the level of evidence available. For stage I disease, vinblastine sulfate seems to be a less effective treatment than the currently accepted standard of care regimen with doxorubicin, bleomycin, and vinblastine.

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