Tegavivint for Wilms Tumor

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dana-Farber/Harvard Cancer Center, Boston, MA
Wilms Tumor+36 More
Tegavivint - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors

See full description

Eligible Conditions

  • Wilms Tumor
  • Refractory Osteosarcoma
  • Recurrent Hepatoblastoma
  • Refractory Non-Hodgkin Lymphoma
  • Refractory Desmoid Fibromatosis
  • Refractory Hepatocellular Carcinoma
  • Refractory Malignant Solid Neoplasm
  • Recurrent Hepatocellular Carcinoma
  • Refractory Ewing Sarcoma
  • Solid Pseudopapillary Neoplasm of the Pancreas
  • Colorectal Carcinoma (CRC)
  • Melanoma
  • Pancreatic Adenocarcinoma (Ductal Adenocarcinoma)
  • recurrent Ewing's Sarcoma
  • Neuroblastoma
  • Ovarian Carcinoma
  • Endometrial Carcinoma
  • Recurrent Desmoid Fibromatosis
  • Recurrent Osteosarcoma
  • Refractory Hepatoblastoma
  • Recurrent Malignant Solid Neoplasm
  • Recurrent Non-Hodgkin Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Wilms Tumor

Study Objectives

This trial is evaluating whether Tegavivint will improve 8 primary outcomes and 1 secondary outcome in patients with Wilms Tumor. Measurement will happen over the course of Up to 2 days.

Day 28
Frequency of dose limiting toxicities of tegavivint
Day 28
Antitumor effects of tegavivint in patients with solid tumors
Up to 2 days
Area under the drug concentration curve of tegavivint
Clearance of tegavivint
Half-life of tegavivint
Maximum serum concentration of tegavivint
Minimum serum concentration of tegavivint
Up to 60 days
Antitumor effect of tegavivint
Up to 60 months
Frequency of adverse events attributable to tegavivint

Trial Safety

Safety Progress

1 of 3

Other trials for Wilms Tumor

Trial Design

1 Treatment Group

Treatment (tegavivint)
1 of 1
Experimental Treatment

This trial requires 38 total participants across 1 different treatment group

This trial involves a single treatment. Tegavivint 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 & 2 and have already been tested with other people.

Treatment (tegavivint)
Drug
Tegavivint will be administered IV over 4 hours on days 1, 8, and 15 of each cycle. Administer D5W flush after completion of each tegavivint infusion. A cycle of therapy is considered to be 28 days. A cycle may be repeated for a total of 26 cycles, up to a total duration of therapy of approximately 24 months. Drug doses should be adjusted based on the weight (height and BSA will also be captured) measured within 7 days prior to the beginning of each cycle. The starting dose will be 5 mg/kg with dose levels for subsequent cohorts increasing to 6.5 mg/kg and 8 mg/kg if excessive toxicity does not occur. If the MTD has been exceeded at the first dose level, then the subsequent cohort of patients will be treated at a dose of 4 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tegavivint
2018
Completed Phase 1
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 60 months for reporting.

Closest Location

Dana-Farber/Harvard Cancer Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Wilms Tumor or one of the other 36 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:
PART A: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
PART B: Patients must be >= 12 months and =< 30 years of age at the time of study enrollment
Patients with recurrent or refractory solid tumors including non-Hodgkin lymphoma and desmoid tumors are eligible. Patients must have had histologic verification of malignancy at original diagnosis or relapse
PART A: Patients with relapsed or refractory solid tumors, including patients with non-Hodgkin lymphoma and desmoid tumors
PART B: Patients with recurrent or refractory Ewing sarcoma, desmoid tumors, osteosarcoma, liver tumors (HCC and hepatoblastoma), Wilms tumor, and tumors with Wnt pathway aberrations. For the Wnt pathway aberrations cohort we will include the most common CTNNB1 mutations (S37F, S45F, T41A, S45P, S33C, S37C, D32Y, S33F, T41I, G34R, G34V, D32N, S33P, G34E, D32G) as well as any loss of function mutations in the APC, Axin2FBXW7, TCF7L2, and RNF43 genes or any gain-of-function mutations in the GSK3B, LRP6, and LGR5 genes. For patients without prior sequencing, immunohistochemistry (IHC), is required. IHC showing strong nuclear beta-catenin staining will be accepted for the following tumor types: colorectal carcinoma, melanoma, endometrial cancer, ovarian cancer, neuroblastoma, non-Hodgkin lymphoma, pancreatic ductal adenocarcinoma, and solid pseudopapillary tumor of the pancreas
PART A: Patients must have either measurable or evaluable disease. For desmoid tumors, the patient must have disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
PART B: Patients must have measurable disease. For desmoid tumors, the patient must have measurable disease that the investigator deems unresectable or sufficiently morbid or potentially life-threatening that there is favorable risk/benefit to the patient to participate in the trial
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive

Patient Q&A Section

What are common treatments for fibroma?

"There was no single or definitive therapy for fibroma. The only treatment that has a high probability (≥ 85%) and acceptable chance of success was an excision. However, even this approach would have a high likelihood of recurrence, especially when the underlying disease was not detected. For this reason, excision should not be attempted unless the patient's age is less than 5 years and is in an early age. When excision fails, and despite the risk, a second excision would be an acceptable next step. However, the probability of recurrence is not negligible in fibroma, which would be particularly prevalent in patients diagnosed later in life and who do not have medical insurance that can cover their medical expenses." - Anonymous Online Contributor

Unverified Answer

What is fibroma?

"Fibroma is a malignant tumor of the lung that may occur in isolation or be associated with other lung diseases. It is most commonly found in women in the 30-50 group of age, has a tendency to grow in a central location in the chest, and usually responds well to anti-cancer chemotherapy and radiation techniques." - Anonymous Online Contributor

Unverified Answer

Can fibroma be cured?

"The most successful case was of an 85-year-old woman, who is now in remission by using the treatment she used originally for [fibroma of the vulva in her history]. However, even then, the success rate of fibroma cure was not the same as the cure rate for [fibroma of the vulva], whose cure rate is 10-15%. Therefore, even though in cases of fibroma of the vulva, if it can be found early, the success rate of [fibroma cure is] lower and if found late, fibroma cannot cure." - Anonymous Online Contributor

Unverified Answer

What are the signs of fibroma?

"Numbness/tingling and a burning sensation are usually present in fibroma of the testis, while skin lesions may take the form of scaly, red papules that form on the scrotum. Scars form from testicular surgery and are often painful in the affected individual." - Anonymous Online Contributor

Unverified Answer

What causes fibroma?

"The development of fibroma seems to involve a complex interaction between genetic and environmental risk factors that result in abnormal cell proliferation and differentiation. Fibroma also occurs in individuals with end-stage manifestations of rheumatoid arthritis, including osteophytes, extraosseous lesions and bone erosions. Osteophytes are a reliable and clinically apparent marker of long-standing subclinical, generalized bone disease even in rheumatoid individuals. Results from a recent clinical trial contributes to the identification of multiple and unique risks for the development of fibroma." - Anonymous Online Contributor

Unverified Answer

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

"around 400,000–500,000 people a year in the United States will be diagnosed with fibroma (benign fibrous tumour of the breast). Most cases occur on the right breast in females. The number of women and males with fibroma may be roughly equal. In an annual interval of 20 years there are expected to be 0.9 male-fibromas and 0.6 female-fibromas per 10,000 women between 35 and 75 years old in USA women. This means that, in an area of 20,000,000 women of 35–75 years old, there are expected 0.99 male-fibromas per 10,000 males (0." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of fibroma?

"Fibroma progresses in young to mid-age women over years, more often with increasing body weight, and tends to progress to the extremities, retroperitoneum, or scrotum." - Anonymous Online Contributor

Unverified Answer

How serious can fibroma be?

"The tumor typically arises along a superficial muscle or over a deep tendon sheath. The usual site of the tumor is on the back, but it can occur in other areas. Fibromas are a rare benign tumor; most people who have it are unaware that they have the disease." - Anonymous Online Contributor

Unverified Answer

Does tegavivint improve quality of life for those with fibroma?

"Results from a recent paper demonstrates that the use of TIV is associated with improved quality of life without overt side effects in patients with fibroma." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets fibroma?

"Fibroma's natural history is unknown. Although some physicians feel the age of 20 may be the preferred time for Fibroma diagnosis due to its tendency to be diagnosed early in life, others feel fibroma is diagnosed at a greater age and is not recommended to postpone Fibroma for its treatment until later, while also pointing to the increased incidence of fibroma in females. The natural history and cause of Fibroma are not entirely clear; however, Fibroma is known to occur more often and on more males than females, and fibroma of males is thought to be related to an increased amount of testosterone." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving tegavivint?

"There have been two clinical trials involving tegavvir, both on subjects coinfected with HIV who received them in the context of ART. The first study involved treatment of 49 HIV-infected patients for 6 months with or with PIs. The HIV status of participants was generally unknown, and there were no significant toxicities reported. The second study involved 15 HIV-positive patients for 12 months, during which they had no antiretroviral drug use restrictions or required adherence monitoring. There were four patients with mild to moderate fatigue, none with nausea or vomiting. There were no significant changes in patient or study data in either trial. The FDA approved tegavir as a treatment, regardless of HIV status and ART-free status." - Anonymous Online Contributor

Unverified Answer

Is tegavivint typically used in combination with any other treatments?

"The combination of TEGAVIVINT with chemotherapy is highly effective. Results from a recent paper of this study can be considered in the context of the current situation of oncological specialists in Afghanistan: the number of advanced cancers is too high that it is difficult to allocate all resources for anticancer therapies. Thus adjunctive therapies are the only way forward." - Anonymous Online Contributor

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