Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Philadelphia Chromosome

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

All Drugs and Chemicals

Vincristine

Tubulin Modulators

Antimitotic Agents

Eligible subjects received study drug at 2.25 mg/m\^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).

Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.

Marqibo® (vincristine sulfate liposomes injection)

Susan O'Brien, MD

This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemotherapy. The original enrollment target for this study was approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65.

The primary objective of this study was to evaluate:

- The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.

The secondary objectives of this study were to evaluate:

* Duration of CR plus CRi
* Overall survival
* Safety and tolerability

Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia

A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine Sulfate Liposomes Injection) in Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy

CR is defined as no evidence of ALL: ANC\>or=1x10\^9/L or platelet count\>100x10\^9/L, absence of leukemia blast cells in blood and marrow (\<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count\< 100x10\^9/L or ANC\< 1x10\^9/L. Partial remission(PR):CR with\>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB\<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.

Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC\>=1X10\^9/L or Platelet count\>=100x10\^9/L, absence of blasts in blood and morrow (\<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count \<100x10\^9/L or ANC\<1x10\^9/L.

Duration of response for those subjects who achieved CR or CRi

Time, in days, from informed consent date until the date of death or date of last contact

Parexel

Spectrum Pharmaceuticals, Inc

Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).

Marqibo

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Canada

Israel

Germany

Region of Enrollment

Chief Medical Officer

Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon's 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.

Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)

Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.

Eligible subjects received Marqibo at 2.25mg\^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)

Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)

Duration of CR + CRi

The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.

Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)

Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)

Overall Survival

Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.

Eligible subjects received Marqibo at 2.25mg\^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)

The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.

Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation

Overall Study

Skin and Connective Tissue Diseases

Wounds and Injuries

Behaviors and Mental Disorders

Breast Neoplasms

Neoplasm Metastasis

Carcinoma

Adenocarcinoma

Hyperthermia

Carcinoma, Ductal

Fever

Carcinoma, Ductal, Breast

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Antirheumatic Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

LTLD in combination with MR-HIFU induced hyperthermia and cyclophosphamide

Single arm study

Patients will receive up to six cycles at three-weeks intervals of:

* Intravenous LTLD dosed at 50mg/m2 administered during the MR-HIFU treatment
* 60 minutes of MR-HIFU mild local hyperthermia at 40 °C - 42 °C to the primary breast tumour
* Intravenous Cyclophosphamide 600 mg/m2 after MR-HIFU treatment

In case of toxicity, LTLD, cyclophosphamide and/or hyperthermia dosages will be adjusted as specified in the study protocol.

LTLD

Patients will receive up to six cycles at three-weeks intervals of:

- 60 minutes of MR-HIFU mild local hyperthermia at 40 °C - 42 °C to the primary breast tumour.

In case of toxicity, hyperthermia dosages will be adjusted as specified in the study protocol.

MR-HIFU induced hyperthermia

Patients will receive up to six cycles at three-weeks intervals of:

- Intravenous Cyclophosphamide 600 mg/m2 after MR-HIFU treatment

In case of toxicity, cyclophosphamide dosages will be adjusted as specified in the study protocol.

Mirjam A de Visser, MD

Britt BM Suelmann, MD

In this phase I feasibility study, the investigators evaluate the combination of lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) with local hyperthermia and cyclophosphamide (C), for the local treatment of the primary breast tumour in patients with metastatic breast cancer.

When heated to 40-43 degrees Celsius (ºC), LTLD releases a very high concentration of doxorubicin locally within seconds. Hyperthermia of the primary tumour will be induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) on a dedicated Sonalleve MR-HIFU breast system.

The investigators hypothesize that by substituting doxorubicin (A) in the AC-chemotherapy regimen for the combination of LTLD and MR-HIFU induced hyperthermia, optimal local tumour control can be achieved without compromising systemic toxicity or efficacy.

This will be the first study to evaluate LTLD with MR-HIFU hyperthermia in breast cancer patients.

Advances in systemic treatment led to improved overall survival in patients with metastatic breast cancer. Various studies suggest that by obtaining loco-regional control, overall survival in advanced disease can further be improved.

Pre-operative chemotherapy can be used in metastatic breast cancer to make radical removal of the primary tumor feasible, while simultaneously maintaining control of already present metastatic sites. The doxorubicin and cyclophosphamide regimen (AC) is well-known both in (neo-)adjuvant setting as in treatment of metastatic breast cancer. At present, optimal local control in advanced breast cancer using adequate dosing of doxorubicin is hampered by its toxic systemic effects. Therefore the investigators aim to increase doxorubicin deposition in the primary tumor without interfering with systemic efficacy and toxicity, by combining lyso-thermosensitive liposomal doxorubicin (LTLD, ThermoDox) with local mild hyperthermia, induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). When heated to 40-43 ºC, ThermoDox releases a very high concentration of doxorubicin locally within seconds. In the absence of hyperthermia, ThermoDox leads to a similar biodistribution and antitumor efficacy to free doxorubicin. MR-HIFU allows for controlled heating of deep-seated tumors.

This is a single-arm phase I feasibility study in 12 patients with de novo stage IV (distant metastasis at the time of diagnosis) her2-negative breast cancer, who have not received previous chemotherapy. The study treatment consists of up to 6 cycles at 21-day intervals of ThermoDox (50mg/m2) administered during MR-HIFU induced hyperthermia (60 minutes at 40-42 ᵒC) and cyclophosphamide (600 mg/m2) administered afterwards. A dedicated MR-HIFU breast system integrated with a clinical 1.5 Tesla Magnetic Resonance Imaging (MRI) scanner will be used for safe and controlled heating of the tumour. Primary endpoints are safety, tolerability and feasibility. Secondary endpoint is efficacy, assessed by radiological response of the local tumor and the distant metastases.

In the Biobank side study, extra blood samples will be collected. These samples will be used for further research on not yet determined topics related to breast cancer.

Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer

Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer. Phase I Feasibility Study of Hifu-Induced Hyperthermia, LTLD and Cyclophosphamide for Metastatic Breast Cancer

Safety and tolerability of the study treatment

Tolerability of the study treatment. Scores will be described.

Dutch Cancer Society

Center for Translational Molecular Medicine

Vrienden UMC Utrecht

UMC Utrecht

Principal Investigator

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Hypersensitivity

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplastic Processes

Hematinics

Liver Extracts

ThermoDox administered as single dose intravenously over 30 minutes in combination with radiofrequency ablation. Dose is determined by dose cohort patient enters study.

15 ml vial containing 2mg/ml Doxorubicin HCl, DPPC, MSPC, DSPE-MPEG 2000. Administered as single dose intravenously over 30 minutes. Dose is determined by dose cohort patient enters study.

ThermoDox

The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when used in combination with radiofrequency ablation (RFA) in the treatment of primary and metastatic tumors of the liver.

Ablative treatment approaches, such as RFA or microwave ablation, have received increased attention as alternates to other treatment approaches such as hepatic arterial embolization or chemoembolization (TACE) or percutaneous ethanol injection (PEI) in the majority of patients who are either not candidates for surgical resection or are not offered palliative supportive care only for diffuse disease. RFA can be applied repetitively to the same patient to treat multiple tumors at time of diagnosis or upon tumor recurrence (local or distant to the site of ablation), and is largely limited in its application only by tumor location and size (tumors near larger vessels, bowel or the hepatobiliary tree are more difficult to ablate). To extend the volume of the ablation region in a controlled fashion in patients and to improve the ability to kill tumor cells in the ablation margin region and allow for the improved treatment of HCC and MLC lesions \> 3 cm in diameter by complete thermal ablation, Celsion Corporation has developed ThermoDox, a thermally sensitive, intravenously administered liposomal formulation of doxorubicin capable of selectively releasing its drug contents when exposed to temperatures of \> 39.5°C. The concept behind this treatment approach is to create a large concentration gradient of doxorubicin in the immediate region of the tumor which borders the zone of RFA induced cell necrosis. The temperature isotherms produced in this boundary region should be adequate to activate doxorubicin release by the thermally sensitive liposomes deposited locally around the ablation zone. This in effect increases the region of tissue that can be treated beyond that achievable by RFA alone. Several clinical objectives are being tested in this study. The MTD for ThermoDox is to be confirmed. This study will assess the safety of using ThermoDox in conjunction with RFA over multiple cycles, consistent with the clinical needs of the subjects. While this study is not powered to define effectiveness of the combination of RFA plus ThermoDox, the results of this study should allow for an assessment of risk and benefit for designing future studies. This study will also test alternative infusion reaction prophylaxis regimens.

A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver

A Phase I Dose Escalation Tolerability Study of ThermoDox™ (Thermally Sensitive Liposomal Doxorubicin) in Combination With Radiofrequency Ablation (RFA) of Primary and Metastatic Tumors of the Liver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia	NCT00495079	Acute Lymphobla...	Marqibo® (vincr...	18 Years -	Spectrum Pharmaceuticals, Inc
Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia	NCT00495079	Acute Lymphobla...	Marqibo® (vincr...	18 Years -	Spectrum Pharmaceuticals, Inc
Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer	NCT03749850	Metastatic Brea... Breast Cancer Breast Neoplasm... Stage IV Breast... Metastatic Canc... Invasive Ductal... Invasive Ductal... Adenocarcinoma ...	LTLD MR-HIFU induced... Cyclophosphamid...	18 Years -	UMC Utrecht
A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver	NCT00441376	Hepatocellular ... Liver Neoplasms	ThermoDox	18 Years -	Imunon
Image-guided Targeted Doxorubicin Delivery With Hyperthermia to Optimize Loco-regional Control in Breast Cancer	NCT03749850	Metastatic Brea... Breast Cancer Breast Neoplasm... Stage IV Breast... Metastatic Canc... Invasive Ductal... Invasive Ductal... Adenocarcinoma ...	LTLD MR-HIFU induced... Cyclophosphamid...	18 Years -	UMC Utrecht

Spots Global Cancer Trial Database for liposome

Every month we try and update this database with for liposome cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for liposome

Every month we try and update this database with for liposome cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for liposome cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.