Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Leukemia, Erythroblastic, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Acute Erythroid Leukemia

Di Guglielmo's Syndrome

Chronic Myeloproliferative Disorders

Antineoplastic Agents

All Drugs and Chemicals

Venetoclax

Azacitidine

All patients with rrAML are treated with HVA regimen

venetoclax with a dose of 400mg per day for 14 days, combined with azacitidine (AZA) with a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days

HVA Regimens as Salvage Treatment

Qifa Liu

Up Until now, there is not well acepted treatment for relapsed/refractory (rr) acute myeloid luekemia (AML), which has low complete response and poor survival. According to different guildlines, clinical trial is the first choice for the treatment of rrAML. High expression of BCL-2 and hypermethylation are very important factors for drug resistance in AML. Lots of studies have reported combination of BCL-2 inhibitor with hypomethylating agents (HMA) showed a promising efficacy in elder or unfit patients with newly diagnosed AML, however, presented not that exciting curing effect in rrAML. It is known that overexpression of MCL-1 and BCL-XL is the main reason for leukemia cells being resistant to BCL2 inhibitors. Since Homoharringtonine (HHT) could downregulate MCL-1 and BCL-XL in leukemia cells, there might be a synergic effect for combination of BCL-2 inhibitors with HHT, which has been proven in the treatment of lymphoma. Yet, there is not a report for the use of this combination in AML. In this single arm multi-centers prospective study, adult patients with rrAML are included and treated with BCL-2 inhibitor venetoclax at a dose of 400mg per day for 14 days, combined with azacitidine (AZA) at a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days, and then the eficacy and safety of HVA regimens as salvage treatment in rrAML are assessed.

Patients with rrAML are treated with HVA regimen

Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML

Efficacy and Safety of HVA Regimens as Salvage Treatment in Relapsed/Refractory (rr) Acute Myeloid Leukemia (AML)

Blast rate lower than 5% with or without peripheral blood cell recover

The number of participants experiencing 3/4 degree bone marrow suppession and infection.

Shenzhen Second People's Hospital

The Seventh Affiliated Hospital of Sun Yat-sen University

Maoming People's Hospital

Sun Yat-sen Memorial Hospital,Sun Yat-sen University

Shenzhen Hospital, Southern Medical University

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

The First People's Hospital of Chenzhou

Peking University Shenzhen Hospital

Zhongshan People's Hospital, Guangdong, China

Nanfang Hospital, Southern Medical University

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Active monitoring of patients with low volume metastases with Prostate Specific Antigen (PSA) and sequential imaging.

Surgical or radiotherapy treatment of metastases.

Surveillance

Surgical removal of metastases, or stereotactic body radiotherapy of metastases.

Salvage treatment

Gert De Meerleer, PhD, MD

Prostate cancer patients diagnosed with a biochemical recurrence and limited metastases are conventionally treated with androgen deprivation therapy. However, in patients with limited metastatic load, the time to progression might be. Subsequently, active surveillance of these patients until progression might defer the start of androgen deprivation therapy (ADT) for several months to years. As an alternative, salvage treatment of the limited number of metastases with either surgery or radiotherapy might postpone the start of ADT even longer. The current trial hypothesizes that ADT might be deferred longer following salvage treatment as compared to active surveillance.

Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer

Salvage Treatment or Active Clinical Surveillance for Oligometastatic Prostate Cancer: a Randomized Phase II Trial

Androgen deprivation therapy free survival will be calculated from randomization until androgen deprivation therapy is started.

Questionnaire: European Organisation for Research and Treatment of Cancer Quality Of Life C30 (EORTC QLQ C30)

Questionnaire: Short Form (36) Health Survey (SF36)

University Hospital, Ghent

Digestive System Diseases

Adenocarcinoma

Stomach Neoplasms

Stomach Cancer

Paclitaxel

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)

nab-Paclitaxel

John Souglakos, MD

Vassilis Georgoulias, MD

The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction

Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.

Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer

A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.

Documented response rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response

Documented disease control rate will be assessed every two months (8 weeks) until disease progression according to common criteria for tumor response

From date of randomization until the date of first documented progression or date of death from any cause, whichever come first, assessed up to 108 weeks

From date of randomization until the date of last follow up or death from any cause, assessed up to 108 weeks

Hellenic Oncology Research Group

Rectal Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Neuroendocrine Tumor

Neuroepithelioma

patients with salvage treatment after endoscopic resection were diagnosed as having positive resection margin status

patients without salvage treatment after endoscopic resection were diagnosed as having positive resection margin status

salvage radical surgery or endoscopic resection

salvage treatment

we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.

Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors

Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study

Yanhong Deng

M.D.

Germ Cells Tumors

Cisplatin

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Olaparib dispensed to patients at the dose of 300 mg twice daily (BID) continuously until the patient completes the study, withdraws from the study or closure of the study.

Ugo De Giorgi, MD

Sandro Pignata, MD

This is open-label, single-arm, two-stage phase II trial of olaparib in patients with relapsed/refractory metastatic germ cell cancer. The primary objective is to evaluate the preliminary activity of Olaparib in GCT tumors. The secondary objective is to evaluate the safety of Olaparib in patients with cisplatin-refractory GCT.

This is a proof-of principle open-label, single-arm, two-stage phase II trial of olaparib 300 mg twice daily in patients with relapsed/refractory metastatic germ cell cancer. The study will recruit 10 patients, if no response is seen the study is terminated. If one or more responses are observed, further 19 patients (for a total of 29 patients) will be enrolled. If 4 or more of the first 29 evaluable patients have achieved objective response, further studies in patients with metastatic germ cell cancer are warranted.

The main inclusion criteria are:

* Patient with metastatic gonadal GCT or extragonadal GCT originating from retroperitoneum or mediastinum.
* Disease progression during cisplatin-based chemotherapy or disease progression or relapse after high-dose chemotherapy or disease progression or relapse after at least 2 different cisplatin-based regimens
* At least one measurable lesion that can be accurately assessed by CT/MRI/plain x-ray) at baseline and follow up visits.

The study will be analyzed on an intent-to-treat basis. Secondary parameters will be analyzed exploratively for the intent-to-treat population.

Correlations between with biomarkers (PAR, poly adenosine diphosphate-ribose polymerase (PARP-1), PTEN, XPA, ERCC1-3, XPF, FanD2, γ-H2AX) expression in paraffin-embedded tumor samples and clinical outcome will be performed in an exploratory intent. Plasma samples will be collected at baseline and at response/progression for possible retrospective biomarkers study.

Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor

The percentage of patients whose cancer achieve either a partial response or a complete response.Tumor response will be assessed using CT scan or MRI of chest/abdomen using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and by tumor marker (AFP, betaHCG, LDH) measurements

All patients will be evaluable for toxicity from the time of their first treatment with Olaparib

time from the date of starting of the treatment to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

Time from enrolment to the date of death due to any cause. For subjects with no known date of death, survival time will be censored at the date of their last on-study assessment.

correlation between biomarkers (PAR, PARP-1, PTEN, XPA, ERCC1-3, XPF, FanD2, γ-H2AX) in paraffin-embedded tumor samples and plasma with clinical outcome (response, PFS, OS)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of HVA Regimens as Salvage Treatment in rrAML	NCT04424147	Refractory Acut... Relapsed Acute ... Salvage Treatme... HVA Regimen	HVA Regimens as...	18 Years - 65 Years	Nanfang Hospital, Southern Medical University
Non-systemic Treatment for Patients With Low-volume Metastatic Prostate Cancer	NCT01558427	Prostate Cancer	Surveillance Salvage treatme...	18 Years - 80 Years	University Hospital, Ghent
Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer	NCT02251951	Stomach and Gas...	nab-Paclitaxel	19 Years -	Hellenic Oncology Research Group
Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors	NCT06143605	Rectal Neoplasm... Neuroendocrine ...	salvage treatme...	18 Years - 65 Years	Sun Yat-sen University
Olaparib as Salvage Treatment for Cisplatin-resistant Germ Cell Tumor	NCT02533765	Neoplasms, Germ...	Olaparib	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Spots Global Cancer Trial Database for salvage treatment